Use Of Seprafilm Research Articles

Seprafilm® and adhesive small bowel obstruction in colorectal/abdominal surgery: an updated systematic review

BackgroundThe efficacy of Seprafilm® in preventing clinically significant adhesive small bowel obstruction (ASBO) is controversial and deserves further review. The aim of this review was to assess the utility of Seprafilm® in preventing clinically significant adhesive bowel obstruction after abdominal operations, with separate focus on colorectal resections. The secondary aim was to provide an updated literature review on the safety profile of this implant.MethodsAn up-to-date systematic review was performed on the available literature between 2000 and 2023 on PubMed, EMBASE, Medline, and Cochrane Library databases. The main outcome measures were rates of adhesive bowel obstruction, as well as rates of intervention. The secondary outcome was the clinical safety profile of Seprafilm® as described in current literature.ResultsA total of 17 observational studies were included, accounting for 62,886 patients. Use of Seprafilm® was associated with a significant reduction in adhesive bowel obstruction events (OR 0.449, 95% CI: 0.3271 to 0.6122, p < 0.001), with preserved efficacy seen in laparoscopic cases. This did not translate into a reduced rate of reintervention. Clinicians should also be aware of isolated reports of a paradoxical inflammatory reaction leading to fluid collections after Seprafilm® use, although they appear uncommon.ConclusionSeprafilm® can be considered in select patients although further study to determine which patients will benefit most is required.

P-022 USE OF SEPRAFILM ADHESION BARRIER® IN COMPLEX LARGE INCISIONAL HERNIA

Abstract Aim The short-term results of the use of seprafilm® as a reinforcement of the peritoneum are presented. Material and Methods Seprafilm® was used in 5 patients with large midline and lateral incisional hernia in which Transversus Abdominis Release Technique was performed in which it was necessary to explant mesh previously. This weakness of the peritoneum was reinforced with the seprafilm® plates, to isolate the intra-abdominal contents from the mesh. Results The patients treated had an average stay of 6.6 days. All of them carried drains. There were no infectious complications in surgical site. There were no prolonged pain. All of them began tolerance the day after the surgery. At one month of the surgical intervention, there were no signs of infection, seroma or higher pain than 3 on the EVA scale. Discussion Post-operative adhesions to mesh are related to intestinal fistulas. The use of preperitoneal space to place the mesh is a good option, although sometimes it can have continuity problems, especially when there are explants of previous materials. The use of barrier materials is appropriate in these cases. Conclusion The use of Seprafilm® can be a good option as a barrier between viscera and prostheses for the prevention of adhesions.

SP10.1.6 Effect of hyaluronate-based bioresorbable membrane (Seprafilm) on outcomes of abdominal surgery: a meta-analysis and trial sequential analysis of randomised controlled trials

Abstract Background We aimed to evaluate comparative outcomes of abdominal surgery with and without hyaluronate-based bioresorbable membrane (Seprafilm). Methods We conducted a systematic search of electronic databases and bibliographic reference lists with application of a combination of free text and controlled vocabulary search adapted to thesaurus headings, search operators and limits. Small bowel obstruction, anastomotic leak, surgical site infections, ileus, and severity of adhesions were the evaluated outcome measures. Results Thirteen randomised controlled trials reporting a total of 3,665 patients evaluating outcomes of abdominal surgeries with (n=1,800) or without (n=1,865) use of Seprafilm were identifed. Use of Seprafilm was associated with significantly lower risk of small bowel obstruction (RR:0.53, 95% CI 0.38–0.73, P=0.0001) but significantly higher rate of anastomotic leak (RR: 1.85, 95% CI 1.15–3.00 P=0.01). Moreover, while Seprafilm resulted in significantly more adhesions-free patients (RR:5.57, 95% CI 3.37–9.19, P&amp;lt;0.0001) compared to no Seprafilm, its use was associated with significantly lower grade 2 (RR:0.57, 95% CI 0.35–0.95, P=0.003) or 3 (RR:0.31, 95% CI 0.17–0.55, P&amp;lt;0.0001) adhesions. There was no significant difference in surgical site infection (RR:1.21, 95 CI 0.86–1.70, P=0.28), intra-abdominal abscess (RR: 1.46, 95 CI 0.92–2.32, P=0.11) or paralytic ileus (RR:0.97, 95 CI 0.68–1.38, P=0.87) between two groups. The trial sequential analysis demonstrated that the meta-analysis findings are conclusive. Conclusions Seprafilm reduces the risk of small bowel obstruction and severity of adhesions after abdominal surgery. However, it may increase the risk of anastomotic leak. We recommend use of Seprafilm in any abdominal surgery which does not involve an anastomosis.

Pregnancy Outcomes Following Minimally Invasive Vs Open Myomectomy

<h3>Study Objective</h3> The impact of myomectomy on subsequent pregnancies, whether performed open or minimally invasively, is not fully understood. We aim to characterize pregnancy outcomes and complications following myomectomy. <h3>Design</h3> We performed a retrospective review of all patients who underwent myomectomy from 2010-2018 (n=881) and identified all patients who had a subsequent delivery greater than 24 weeks (n=147). Operative reports and discharge summaries were reviewed to identify surgical factors, including the use of adhesion barriers, and complications at the time of myomectomy, as well as pregnancy complications including rates and severity of adhesions at the time of C-section. <h3>Setting</h3> A large academic hospital. <h3>Patients or Participants</h3> Women who underwent myomectomy followed by delivery. <h3>Interventions</h3> N/A. <h3>Measurements and Main Results</h3> 85 patients underwent MIS myomectomy and 61 underwent open myomectomy. During pregnancy, there were no statistically significant differences in the rates of placenta accreta (P=0.578, overall rate 0.6%), placenta previa (P=0.546, overall rate 3.4%), EBL during C-section (P=0.546), or rates of complications such as fetal growth restriction (P=0.463, overall rate 1.4%), fetal demise (0.916, overall rate 1.4%), or PPROM (P=0.225, overall rate 1.4%). Adhesions noted at the time of C-section were higher in in the open group compared to the minimally invasive group (P=0.011) and rates of severe adhesions (resulting in bladder or bowel injury or requiring classical C-section) were also higher in the open group as compared to the MIS group (P=0.006). The use of intercede significantly reduced rates of clinically significant adhesions (P= 0.019) whereas the use of Seprafilm or Tisseal did not (P=0.528, 0.323 respectively). <h3>Conclusion</h3> The use of MIS techniques, as well as the use of the adhesion barrier intercede, reduce the rates of clinically significant adhesions at the time of C-section. Other pregnancy outcomes are not impacted by the use of minimally invasive techniques in our sample.

Effect of hyaluronate-based bioresorbable membrane (Seprafilm) on outcomes of abdominal surgery: a meta-analysis and trial sequential analysis of randomised controlled trials.

We aimed to evaluate comparative outcomes of abdominal surgery with and without hyaluronate-based bioresorbable membrane (Seprafilm).We conducted a systematic search of electronic databases and bibliographic reference lists with application of a combination of free text and controlled vocabulary search adapted to thesaurus headings, search operators and limits. Small bowel obstruction, anastomotic leak, surgical site infections, ileus, and severity of adhesions were the evaluated outcome measures. Thirteen randomised controlled trials reporting a total of 3665 patients evaluating outcomes of abdominal surgeries with (n = 1800) or without (n = 1865) use of Seprafilm were identified. Use of Seprafilm was associated with significantly lower risk of small bowel obstruction (RR 0.53, 95% CI 0.38-0.73, P = 0.0001) but significantly higher rate of anastomotic leak (RR 1.85, 95% CI 1.15-3.00 P = 0.01). Moreover, while Seprafilm resulted in significantly more adhesions-free patients (RR 5.57, 95% CI 3.37-9.19, P < 0.0001) compared to no Seprafilm, its use was associated with significantly lower grade 2 (RR 0.57, 95% CI 0.35-0.95, P = 0.003) or 3 (RR 0.31, 95% CI 0.17-0.55, P < 0.0001) adhesions. There was no significant difference in surgical site infection (RR: 1.21, 95 CI 0.86-1.70, P = 0.28), intra-abdominal abscess (RR 1.46, 95 CI 0.92-2.32, P = 0.11) or paralytic ileus (RR 0.97, 95 CI 0.68-1.38, P = 0.87) between two groups. The trial sequential analysis demonstrated that the meta-analysis findings are conclusive. Our meta-analysis demonstrated that Seprafilm reduces the risk of small bowel obstruction and severity of adhesions after abdominal surgery. However, it may increase the risk of anastomotic leak. We recommend use of Seprafilm in any abdominal surgery which does not involve an anastomosis.

Risk factors of vaginal cuff infection in women undergoing laparoscopic hysterectomy for benign gynecological diseases.

This study aimed to identify the risk factors for vaginal cuff infection after laparoscopic hysterectomy for benign gynecological diseases. We conducted a retrospective cohort study among 1559 Japanese women who underwent total laparoscopic hysterectomy (TLH) for benign indications between 2014 and 2018 at Teine Keijinkai Hospital in Sapporo, Japan. All patients received preoperative antibiotics based on appropriate timing, choice, and weight-based dosing. We assessed the risk factors of vaginal cuff infection after TLH, including demographic and clinical variables, and patient- and surgery-related factors, using univariable and multivariable logistic regression analyses. Among all the patients who underwent TLH, 71 cases of vaginal cuff infections (4.6%) were recorded. Univariate analyses showed that current smoking, pathological result of adenomyosis, use of Seprafilm as an antiadhesive material, white blood cell counts on postoperative day (POD) 2, C-reactive protein (CRP) level on POD2 and postoperative vaginal cuff hematoma were significantly associated with an increased risk of vaginal cuff infection. In multivariate analysis, current smoking, use of seprafilm, CRP level on POD2 and vaginal cuff hematoma were significantly associated with an increased risk of vaginal cuff infection. Current smoking, use of seprafilm, CRP level on POD2 and vaginal cuff hematoma were identified as significant risk factors of vaginal cuff infection in the 30 days after surgery in Japanese women who underwent TLH for benign indications.

Effect of sodium hyaluronate-arboxycellulose membrane (Seprafilm®) on postoperative small bowel obstruction: A meta-analysis

BackgroundThis meta-analysis was performed to evaluate the effect of Seprafilm® on postoperative small bowel obstruction. MethodsA literature search was conducted in the PubMed and EMBASE databases through August 2020. The pooled risk ratios as well as the corresponding 95% confidence intervals were calculated using RevMan 5.3 software. ResultsA total of 9 clinical control trials involving 4,351 patients (2,123 in the Seprafilm® group and 2,228 in the control group) were included. The overall analysis showed that the pooled risk ratio was 0.45 (95% confidence interval = 0.34–0.60; P < .00001), indicating that the risk of postoperative small bowel obstruction can be significantly decreased by the application of Seprafilm®. Similarly, an obvious effect of Seprafilm® on reducing the rate of postoperative small bowel obstruction was also shown in the subgroup analyses by population (adult participants), study design (randomized control study or nonrandomized control study), region (Japan or Korea), follow-up duration (2 years or 5 years), and sheet number of Seprafilm® (1 sheet or >1 sheet). ConclusionIn conclusion, the use of Seprafilm® is beneficial for decreasing the rate of postoperative small bowel obstruction.

Hyaluronic acid/ carboxymethyl cellulose-based adhesion barrier reduces surgical difficulty and complication in repeat hepatectomy

BackgroundThere has been no solid evidence regarding the actual efficacy of adhesion barriers in liver surgery. MethodsDifficulty grade of lysis of adhesion was evaluated in 122 patients who underwent repeat hepatectomy (ReHx) using the TORAD score. Technical difficulty of lysis of adhesion and incidence of complication were then compared between the group of patients who received a sheet-type adhesion barrier (Seprafilm®) in the previous hepatectomy (n = 70) and those who did not (n = 52) using the inverse probability weighting method. ResultsUse of Seprafilm was significantly associated with lower grade of difficulty of lysis of adhesion according to the TORAD score (P < 0.001). Postoperative morbidity rate was lower and postoperative stay was shorter in the Seprafilm group in the propensity-score adjusted population (37% vs. 74%, P < 0.001 and 12 days vs. 14 days in median, P = 0.048). Multivariate analysis confirmed that use of Seprafilm was independent predictor for severity of adhesion (odds ratio [OR] 0.24, 95% CI, 0.09–0.65, P = 0.005) and decreased incidence of postoperative morbidity at ReHx (OR, 0.34; 95% CI, 0.14–0.84, P = 0.020). ConclusionsUse of Seprafilm may be associated with decreased technical difficulty of lysis of adhesion and may correlate with lower risk of postoperative morbidity in patients undergoing ReHx.

Safety of bioabsorbable membrane (Seprafilim®) in hepatectomy in the era of aggressive liver surgery

BackgroundRepeat hepatectomy has been recognized as an effective treatment for hepatic malignancies, and a sheet type adhesion barrier, Seprafilm® has increasingly been used during hepatectomy to ease future relaparotomy. However, there is not yet sufficient evidence to support the safety of use of Seprafilm in liver surgery. MethodsData of 151 patients who had undergone open hepatectomy were retrospectively reviewed and the incidence of major abdominal morbidity was compared between patients in whom Seprafilm had and had not been used. ResultsSeprafilm was used in 108 patients (Seprafilm group) and no adhesion barrier was used in 43 patients (comparison group). There was no significant difference in the rate of major abdominal morbidities between the two groups (Seprafilm vs. comparison: 10% vs. 16%, P = 0.403). Although the Seprafilm group showed a tendency toward increased incidence of bile leakage (7% vs. 2%), and placement of Seprafilm on the hepatoduodenal ligament or on the visceral surface of the liver seemed to be associated with an increased incidence of major morbidity, multivariate analysis showed no significant correlation between the use of Seprafilm and postoperative major abdominal morbidity. ConclusionUse of Seprafilm may not increase the risk of major abdominal morbidity in liver surgery.

Is liquid-based hyaluronic acid equivalent to sodium hyaluronate-based bioresorbable membrane to reduce small bowel obstruction in patients undergoing colorectal surgery

We performed a prospective randomized study to assess whether the use of sodium hyaluronate-based bioresorbable membrane (Seprafilm®) and liquid-based hyaluronic acid and carboxymethyl cellulose solution (Guardix) to reduce postoperative small bowel small bowel obstruction in patients undergoing colorectal surgery. This study aimed to compare the incidence of postoperative bowel obstruction. One hundred seven patients were assigned to the Seprafilm® group and 155 were assigned to the Guardix® group during the study period. The control group of 166 patients received no anti-adhesive. Patients were randomly assigned. The overall small bowel obstruction rate was 7.6% (N=37/488 patients). Small bowel obstruction developed in 9 patients (5.8%) in the Guardix® group and 9 patients (7.1%) in the Seprafilm® group and 19 patients (11.4%) in the control group. Seprafilm® group had significantly lower obstruction rate as compared to control group (P=0.036). Guardix® solution and Seprafilm® did not alter the liver and renal function, as assessed by the blood chemistry. The use of Seprafilm significantly reduces the incidence of postoperative small bowel obstruction in patients undergoing colorectal surgery. We observed no difference in the incidence of postoperative small bowel obstruction after the application of Seprafilm® and Guardix® in patients undergoing colorectal surgery.

4回の開腹術下セプラフィルム^[○!R]使用により癒着を防止した両側性ウイルムス腫瘍の1小児例

4回の開腹術下セプラフィルム^[○!R]使用により癒着を防止した両側性ウイルムス腫瘍の1小児例

A new treatment for retroperitoneal fibrosis: initial experiences of using Seprafilm® to wrap the ureter

To confirm the efficacy of using Seprafilm® (Genzyme Corp., Cambridge, MA, USA) for wrapping the ureter to treat the ureteric stenosis caused by retroperitoneal fibrosis (RPF). Between August 2010 and September 2012, 11 ureters in eight patients with RPF (seven males and one female, mean age 65 years) were treated. The mean (range) length of the narrow segment of the ureter was 30 (10-90) mm. During surgery, after having been released from adhesive tissue, the stenotic segment of the ureter was wrapped with Seprafilm to isolate it from the surrounding tissue. A radiographic follow-up was performed every 6 months using computed tomography, i.v. pyelography and/or (99m) Tc-mercapto-acetylglycyl-glycyl-glycine ((99m) Tc-MAG3) renal scintigraphy. For the unilateral operations, the mean estimated blood loss was 39 mL, and the mean operating time was 154 min. All ureters were isolated from the fibrotic tissue and wrapped with Seprafilm successfully without major complications. During the mean follow-up period of 17 months, no ureteric restenoses were observed in the affected sides, but new stenosis occurred in the contralateral side of the ureter in one patient. Although the follow-up period is still limited, we believe that the use of Seprafilm has the potential to become an effective option in the treatment of ureteric stenosis caused by RPF, when the omentum cannot be used. To establish the relative advantages of using Seprafilm over performing a standard omental wrap, further experimentation will be required to compare the two techniques.

滅菌手袋を用いた癒着防止剤（セプラフィルム®）貼付における工夫

Laparoscopic surgery results in less postoperative adhesions than a laparotomy, and the adhesion barrier (Seprafilm®) is used for reducing adhesion formation. Seprafilm®, a bioresorbable membrane of sodium hyaluronate and carboxymethylcellulose, is effective for adhesion prevention; however, its properties make it difficult to insert into the abdominal cavity and place it at the target area in laparoscopic surgeries. We report a new technique to introduce Seprafilm® for laparoscopic surgeries by using surgical glove fingers. Seprafilm® was cut into 4 x 2.4 cm segments and both surfaces were moistened with wet gauze. The films were rolled for placement in the surgical glove fingers and then the glove fingers were inserted into the abdominal cavity through a 12-mm trocar. The Seprafilm® was then unrolled and placed on the target area after removing it from the glove. Eighty-seven of 96 segments of Seprafilm® were successfully used in 16 patients who underwent total laparoscopic hysterectomy. This method can provide the use of Seprafilm® for laparoscopic surgeries at low cost.

Efficacy of Seprafilm for preventing adhesive bowel obstruction and cost–benefit analysis in pediatric patients undergoing laparotomy

PurposeThis aim of the study is to determine whether the use of Seprafilm reduces the incidence and the medical costs of adhesive bowel obstruction (ABO) in children. MethodsPediatric patients undergoing laparotomy were prospectively assigned to the Seprafilm group, n=441). A historical control group consisted of children without using Seprafilm (n=409). The incidence of ABO during a 24-month follow-up period was compared between the groups. To clarify the cost–benefit relations, expenses for Seprafilm and medical costs for hospitalization related to ABO in the Seprafilm group were compared with the ABO-associated hospitalization costs in the control group. ResultsThe cumulative incidence rate of ABO in the control group was significantly higher than in the Seprafilm group (4.9% vs. 2.0%, p=0.015). Nearly all cases that required adhesiolysis had adhesions to areas other than the incision in both groups. In cost–benefit analysis, cost per patient was $105 higher in the control group than in the Seprafilm group, but this did not reach significance (p=0.63). ConclusionsSeprafilm reduces the incidence of ABO in the pediatric patients undergoing laparotomy. Although associated medical costs in the Seprafilm group were not significantly reduced, use of Seprafilm did not lead to an increase in cost. Wider range of Seprafilm application or an additional anti-adhesion device may help in preventing adhesion to areas other than the incision.

Seprafilm® adhesion barrier: (1) a review of preclinical, animal, and human investigational studies

The aim of this study was to provide a single site resource for investigators, clinicians, and others seeking preclinical, animal, and human investigational studies concerning the postsurgical, anti-adhesion barrier Seprafilm™ (Genzyme Corporation, Cambridge, MA). All published preclinical, animal, human extra-abdominal research as of July 2011 have been summarized and included in this document. Searches of Medline and EMBASE Drugs and Pharmaceuticals databases were conducted for original preclinical, animal, and human extra-abdominal studies involving Seprafilm. Preclinical, animal, and extra-abdominal human investigational studies are the study selection for this manuscript. Intraabdominal use is discussed in the accompanying manuscript. Data extraction includes systematic manuscript review. Summary of preclinical, animal, and extra-abdominal human investigational use of Seprafilm by surgical discipline were gathered for data synthesis. The clinical use of Seprafilm, which was approved by the FDA for intra-abdominal procedures, is supported by preclinical and animal studies relating to general surgical and obstetrical/gynecological applications. Findings from preclinical, animal, and human investigational studies at other sites throughout the body raises the potential for additional human clinical trials to assess efficacy and safety following surgical procedures at non-abdominal locations.

Seprafilm® adhesion barrier: (2) a review of the clinical literature on intraabdominal use

This study seeks to provide a review of the clinical data published as of July 2011 concerning the postsurgical adhesion barrier, Seprafilm (chemically modified hyaluronic acid and carboxymethylcelulose; Genzyme Corporation, Cambridge, MA). Included articles detail the application of Seprafilm for intraabdominal uses that have been approved (on-label) and those considered investigational (off-label) by the FDA. Medline and EMBASE Drugs and Pharmaceuticals databases were searched for all original clinical Seprafilm research published as of July 2011. All human Seprafilm intraabdominal clinical reports and studies, excluding those related to prosthetic mesh were included. Data extraction involved the systematic review of each article. The data synthesis is the summary of Seprafilm human intraabdominal clinical reports and studies describing safety and/or efficacy. The safety and efficacy of Seprafilm in reducing postoperative adhesions has been clearly demonstrated in abdominal and pelvic laparotomy. While reports have described the safe and successful use of Seprafilm following laparoscopy, pediatric laparotomy, and in patients with malignancy and/or infection, the safety and efficacy of Seprafilm use in these procedures has not been definitively established in randomized controlled trials.

Technique for decompressive craniectomy using Seprafilm as a dural substitute and anti-adhesion barrier

Surgeons in abdominal and gynecological fields have pioneered the use of Seprafilm (a chemically modified sodium hyaluronate/carboxymethylcellulose absorbable adhesion barrier, Genzyme Biosurgery, Cambridge, MA, USA) to prevent adhesion but its use outside these specialties is not well documented. The authors have used Seprafilm for craniectomy closure in several patients as a dural substitute and anti-adhesion barrier. During emergent craniectomy, the dura mater is reapproximated and a layer of Seprafilm is placed over the dura as an onlay and anti-adhesion barrier. During subsequent surgery for bone flap replacement, dissection between the dural plane and overlying tissues has been completed easily. There has been minimal adhesion to the underlying Seprafilm/dural layer. The Seprafilm has been incorporated into the surrounding dural plane. No postoperative complications have been noted. Seprafilm’s anti-adhesive properties and biodegradable characteristics make it useful as a dural onlay for craniectomy in which a second surgery is planned.

Effect of Anti-Adhesive Barrier Use on Laryngotracheal Movement After Total Thyroidectomy: An Electrophysiological Study

Impairment of laryngotracheal movement is a possible complication after total thyroidectomy. Here, we aimed to investigate the frequency and extent of impairment of laryngotracheal movement after total thyroidectomy and the effect of anti-adhesive barrier hyaluronic acid-carboxymethylcellulose membrane positioning between strap muscles and laryngotracheal complex on deglutition. The study design is prospective clinical study. Istanbul Training and Research Hospital, Laboratory of Electrophysiology, Istanbul Training and Research Hospital. The patients who underwent total thyroidectomy were selected and dichotomized according to use of seprafilm. Each group consisted of 8 female patients. All patients were assessed clinically and electrophysiologically in the pre/postop period. Electrophysiological investigations included cricopharyngeal muscle (CPM) electromyography (EMG), submental EMG, single bolus analysis [foreburst, reburst, swallowing (pause) patterns], laryngotracheal movement analysis and results were compared between two groups. CPM EMG was normal in both groups. Duration of submental muscle activity during dry and 15cc water swallowing was similar between two groups (P=0.751). Pause duration was shorter in group with seprafilm (P<0.01). Dysphagia limit was 15cc in both groups. The fore/rebound bursts duration, the time of laryngeal elevation, closure and suspension were similar (P=0.954). We concluded that use of seprafilm between larynx and strap muscles during total thyroidectomy does not have any adverse effects on swallowing. Anti-adhesive barrier can be used safely during thyroid surgery.

The Use of Seprafilm as a Biological Barrier in Flap Delay

The Use of Seprafilm as a Biological Barrier in Flap Delay

Adhesion Prevention During Laparotomy

The objective of the study was to determine the long-term effect of the use of a hyaluronic acid-carboxymethylcellulose membrane (Seprafilm) on the incidence of adhesions and subsequent small-bowel obstruction and chronic abdominal complaints after colorectal surgery (Hartmann's procedure). Adhesions occur frequently after abdominal surgery and are the most common cause of bowel obstruction, chronic abdominal pain, and infertility. The risk for adhesion-related readmission in the first 10 years after colorectal surgery is as high as 30%. To reduce the formation of adhesions, a mechanical barrier composed of hyaluronic acid and carboxymethylcellulose was developed, to prevent adherence of tissues after abdominal surgery. Long-term results concerning the incidence of small-bowel obstruction and chronic abdominal pain are lacking. Between April 1996 and September 1998, 71 patients requiring Hartmann's procedure for sigmoid diverticulitis or obstructed rectosigmoid were randomized to either intraperitoneal placement of Seprafilm under the midline and in the pelvis or as a control. Direct visual evaluation of the incidence and severity of adhesions was performed laparoscopically in 42 patients at second-stage surgery for restoration of the continuity of the colon. The results of this study were published in 2002. In 2006, the patients' general practitioners were interviewed by means of a questionnaire concerning their patients' health. The patients who were still alive were interviewed and asked to fill out 2 questionnaires concerning pain and quality of life (VAS-pain score, EQ-5D, and SF-36). In 2009, the medical records of the patients were evaluated for adhesion-related hospital re-admissions. Of the 42 evaluated patients, 35 (16 in the Seprafilm group, 19 in the control group) could be enrolled in the long-term follow-up. Median follow-up was 126 months (range 41-148) for the Seprafilm group and 128 months (range 49-149) months for the control group. Incidence of chronic (3 months or longer existing) abdominal complaints was significantly lower in the Seprafilm group compared with controls (35.3% vs. 77.8%, respectively; P = 0.018). Incidence of small-bowel obstruction showed no significant difference in favor of the Seprafilm group; no small-bowel obstructions occurred in the Seprafilm group, whereas in the control group 2 cases of small-bowel obstruction were found to have occurred. Evaluation of the quality of life questionnaires did not reveal significant differences between the 2 groups. In Hartmann's procedure, Seprafilm placement does not provide protection against small-bowel obstruction. Incidence of chronic abdominal complaints is significantly lower after use of Seprafilm.