The effect of ultrapro or prolene mesh on postoperative pain and well-being following endoscopic Totally Extraperitoneal (TEP) hernia repair (TULP): study protocol for a randomized controlled trial.
BACKGROUND
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).


METHODS
The 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.


CONCLUSIONS
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. 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.


BACKGROUND
The TULP study is registered in the Dutch Trial Register (NTR2131).
Department of Surgery/Hernia Clinic, Diakonessenhuis, Utrecht, The Netherlands. nelleke.schouten@gmail.com
Nelleke
N
Schouten
Thijs
T
van Dalen
Niels
N
Smakman
Sjoerd G
SG
Elias
Geert Jan
GJ
Clevers
Egbert-Jan M M
EJ
Verleisdonk
Paul H P
PH
Davids
Ine P J
IP
Burgmans
D000328:Adult; D004311:Double-Blind Method; D004724:Endoscopy / Q000009:adverse effects / Q000295:instrumentation; D004867:Equipment Design; D006552:Hernia, Inguinal / Q000523:psychology / Q000601:surgery*; D059685:Herniorrhaphy / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D006801:Humans; D008297:Male; D009426:Netherlands; D010147:Pain Measurement; D010149:Postoperative Pain / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control* / Q000523:psychology; D017060:Patient Satisfaction; D018579:Patient Selection; D011126:Polypropylenes; D011446:Prospective Studies; D011788:Quality of Life; D012008:Recurrence; D012107:Research Design; D012720:Severity of Illness Index; D013526:Surgical Mesh; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
D011126:Polypropylenes