Abstract
BackgroundThe purpose of this study was to describe the rationale and design of a randomized controlled trial analyzing the effects of mesh type (Ultrapro versus Prolene mesh) on postoperative pain and well-being following an endoscopic Totally Extraperitoneal (TEP) repair for inguinal hernias (short: TULP trial).Methods and designThe TULP trial is a prospective, two arm, double blind, randomized controlled trial to assess chronic postoperative pain and quality of life following implantation of a lightweight (Ultrapro) and heavyweight (Prolene) mesh in endoscopic TEP hernia repair. The setting is a high-volume single center hospital, specializing in TEP hernia repair. All patients are operated on by one of four surgeons. Adult male patients (≥18 years of age) with primary, reducible, unilateral inguinal hernias and no contraindications for TEP repair are eligible for inclusion in the study. The primary outcome is substantial chronic postoperative pain, defined as moderate to severe pain persisting ≥ 3 months postoperatively (Numerical Rating Scale, NRS 4–10). Secondary endpoints are the individual development of pain until three years after the TEP procedure, the quality of life (QoL), recurrence rate, patient satisfaction and complications.DiscussionLarge prospective randomized controlled studies with a long follow-up evaluating the incidence of chronic postoperative pain following implantation of lightweight and heavyweight mesh in endoscopic (TEP) hernia repair are limited. By studying the presence of pain and quality of life, but also complications and recurrences in a large patient population, a complete efficiency and feasibility assessment of both mesh types in TEP hernia repair will be performed.Trial registrationThe TULP study is registered in the Dutch Trial Register (NTR2131)
Highlights
The purpose of this study was to describe the rationale and design of a randomized controlled trial analyzing the effects of mesh type (Ultrapro versus Prolene mesh) on postoperative pain and well-being following an endoscopic Totally Extraperitoneal (TEP) repair for inguinal hernias
Large prospective randomized controlled studies with a long follow-up evaluating the incidence of chronic postoperative pain following implantation of lightweight and heavyweight mesh in endoscopic (TEP) hernia repair are limited
The incidence of chronic postoperative pain after inguinal hernia repair, as described in the literature, varies significantly (10 to 30 %), which is partially explained by the lack of a clear definition [1,2,3,4]
Summary
The purpose of this study was to describe the rationale and design of a randomized controlled trial analyzing the effects of mesh type (Ultrapro versus Prolene mesh) on postoperative pain and well-being following an endoscopic Totally Extraperitoneal (TEP) repair for inguinal hernias (short: TULP trial). Inguinal hernia repair is one of the most common surgical procedures worldwide. The incidence of hernia recurrence has been the primary endpoint in inguinal hernia studies for many years, but with the introduction of the tension-free mesh repair, recurrence rates have dropped significantly to 2 to 3 % [2]. Chronic pain after inguinal hernia surgery is a common complication. The incidence of chronic postoperative pain after inguinal hernia repair, as described in the literature, varies significantly (10 to 30 %), which is partially explained by the lack of a clear definition [1,2,3,4]. The effect of pain on quality of life is significant, since functional limitations of pain in daily life activities are experienced by 2 % to 20 % of the patients [5]
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