Study comparing single-incision laparoscopy versus multitrocar laparoscopy totally extraperitoneal inguinal hernia repair (TEP) at 2 years

ISRCTN	ISRCTN63754528
DOI	https://doi.org/10.1186/ISRCTN63754528
Protocol serial number	SIL/MTL-TEP:210
Sponsor	Saint-Pierre University Hospital
Funder	Université Libre de Bruxelles

Submission date: 07/08/2017
Registration date: 17/08/2017
Last edited: 13/07/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
An inguinal hernia usually occurs when fatty tissue or a part of the bowel pokes through into the groin at the top of the inner thigh. Multitrocar laparoscopy (MTL) is a popular surgical treatment for inguinal hernia repair. Compared to open techniques, laparoscopic (keyhole surgery) treatment results in less pain, faster recovery, early return to daily activities and better cosmetic results. The next step for inguinal hernia repair is single-incision laparoscopy (SIL), where only a single small incision (cut) is used. SIL totally extraperitoneal repair (SILTEP) has been found to be feasible and safe. Early reports are promising, but the advantages of SILTEP over conventional multitrocar laparoscopic TEP (MTLTEP) have not been clearly defined. The aim of this study is to compare the short and mid-term outcomes of SILTEP and MTLTEP inguinal hernia repair.

Who can participate?
Patients aged over 18 undergoing laparoscopic surgery for inguinal hernia 

What does the study involve?
Participants are randomly allocated into two groups to undergo SILTEP or MTLTEP. Complications during surgery and pain after surgery are recorded. All participants are assessed for complications, inguinal hernia recurrence and days needed to return to daily activities at 7 and 30 days after surgery. During follow-up the participants are contacted by phone to assess their surgical and cosmetic satisfaction.

What are the possible benefits and risks of participating?
SILTEP and MTLTEP inguinal hernia repairs are feasible and safe. Both techniques are commonly performed. SILTEP could reduce complications and improve cosmetic results.

Where is the study run from?
Department of Gastrointestinal Surgery, European School of Laparoscopic Surgery, Saint-Pierre University Hospital, Université Libre de Bruxelles (Belgium)

When is the study starting and how long is it expected to run for?
January 2013 to July 2016

Who is funding the study?
Université Libre de Bruxelles (Belgium)

Who is the main contact?
Prof. Giovanni Dapri
giovanni@dapri.net

Contact information

Prof Giovanni Dapri
Scientific

Saint-Pierre University Hospital Université Libre de Bruxelles
Department of Gastrointestinal Surgery
European School of Laparoscopic Surgery
322, Rue Haute
Brussels
1000
Belgium

ORCID ID	0000-0001-7982-283X
Phone	+32 (0)2 535 41 15
Email	giovanni@dapri.net

Study information

Primary study design	Interventional
Study design	Single-centre randomized prospective interventional clinical trial
Secondary study design	Randomised parallel trial
Study type	Participant information sheet
Scientific title	Prospective randomised study comparing single-incision laparoscopy versus multitrocar laparoscopy totally extraperitoneal inguinal hernia repair (TEP) at 2 years
Study objectives	Single-incision laparoscopy totally extraperitoneal (SILTEP) inguinal hernia repair can reduce the postoperative pain and improve the cosmetic results.
Ethics approval(s)	This study does not require ethics approval. Both surgical procedures are frequently used in inguinal hernia repair and have been reported as feasible and safe.
Health condition(s) or problem(s) studied	Unilateral or bilateral inguinal hernia requiring surgical treatment
Intervention	Participants are randomised using computer-generated randomized numbers in sealed envelopes to either: Single-incision laparoscopy totally extraperitoneal (SILTEP) inguinal hernia repair: A 1.5 cm umbilical scar is created in the opposite region of the hernia to treat and the anterior rectus fascia is opened. A fascial purse-string suture using Vicryl 1 is placed starting at 9 o’clock position. An 11-mm reusable rigid trocar is introduced behind the rectus muscle into the preperitoneal space. The 0° regular scope is advanced into the 11-mm trocar and the preperitoneal space is insufflated. The space is dissected using the optical system from medial to lateral side. At the time of hernia sac retraction, a reusable monocurved grasping forceps is introduced inside the purse-string suture, at 9 o’clock position and parallel to the 11-mm trocar. The hernia sac is reduced, the peritoneal sheet is retracted and the spermatic elements are skeletonized. A 15 cm x 10 cm polypropylene mesh is introduced through the 11-mm trocar. The mesh is adequately positioned using the monocurved umbilical grasper, placing the lateral corner anteriorly to the peritoneal sheet and the medial corner under the pubic bone. Multitrocar laparoscopy totally extraperitoneal (MTLTEP) inguinal hernia repair: The operation start with an infraumbilical vertical incision approximately 1.5-2 cm long and the rectus fascia on the opposite side of hernia is opened. A space is created slightly off the midline behind the rectus muscle and in front of the posterior rectus sheath. Subsequently, a 11-mm reusable rigid trocar is introduced behind the rectus muscle into the preperitoneal space. The 0° regular scope is advanced into the 11-mm trocar and used for blunt dissection of the areolar tissue in the preperitoneal space using a gentle sweeping motion. Under direct visualization, two other 6-mm trocars are placed. In unilateral hernias, the first 6-mm trocar is placed through the midline between the umbilicus and the pubis, while the second 6-mm trocar through the horizontal umbilical line 3 cm internal to the ipsilateral anterior superior iliac spine. In bilateral hernias, two 6-mm trocars are inserted through the horizontal umbilical line, 2-3 cm internal to anterior superior iliac spines. Two atraumatic grasping forceps are used to isolate and reduce the hernia sac, to retract the peritoneal sheet and to skeletonize and accurately identify all spermatic cord structures. A 15 cm x 10 cm polypropylene mesh is appropriately placed. All patients were assessed for early postoperative complications at office consultation on 7 and 30 day from surgery. Late postoperative complications (after 30 days), inguinal hernia recurrences and days to return to ADL were recorded too. The mean follow-up was 27 ± 8 months (SILTEP: 28.37 ± 7.29 months; MTLTEP: 26.42 ± 9.04 months). During follow-up the patients were contacted and consulted by phone call questionnaire. The interview was performed on 30/06/2016. Surgical and cosmetic satisfaction were evaluated.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Mid-term outcomes: 1. Late postoperative complications, measured using the number of umbilical hematoma, inguinal hematoma, inguinal seroma (no case reported), umbilical infection (no case reported), testicular atrophy and chronic pain reported by each patient at follow-up (after 30 days from surgery and during interview) 2. Late inguinal hernia recurrence, measured using the number of inguinal hernia recurrence reported by each patient at follow-up (after 30 days from surgery and during interview) 3. Surgical satisfaction, measured using a numerical rating scale (NRS) at follow-up (during interview) 4. Cosmetic satisfaction, measured using a score questionnaire at follow-up (during interview)
Key secondary outcome measure(s)	1. Perioperative outcomes: 1.1. Operative time, calculated using the time from the skin incision until fascia closure at the end of surgical procedure 1.2. Mesh fixation, measured using the number of tack devices used to fix the mesh (if it was necessary) at the end of surgical procedure. (one tack device was used for each mesh fixed) 1.3. Operative complications, measured using the number of peritoneal tear repair, epigastric vessels injury, corona mortis bleeding and conversion to TAPP (transabdominal preperitoneal) repair during surgical procedure 1.4. Postoperative pain, assessed using a visual analogue scale (VAS) at 6, 12, 18 and 24 hours after surgery 1.5. Hospital stay, measured using the number of days of patient’s hospitalization 2. Short-term outcomes: 2.1. Early postoperative complications, measured using the number of umbilical hematoma, inguinal hematoma, inguinal seroma, umbilical infection (abscess), urinary retention and testicular atrophy at office consultation on 7 and 30 days from surgery 2.2. Early inguinal hernia recurrence, measured using the number of inguinal hernia recurrence reported by each patient at office consultation on 7 and 30 days from surgery 2.3. Days to return to activity daily living (ADL), measured using the number of days necessary to return to ADL for each patient evaluated at consultation on 7 and 30 days from surgery or during the interview
Completion date	31/07/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	210
Key inclusion criteria	1. Adult patients (aged 18 years or over) 2. Unilateral or bilateral inguinal hernia 3. Patient’s approval
Key exclusion criteria	1. Age <18 years 2. Patient refusal to partecipate in the study 3. Inability to receive general anesthesia 4. Concomitant surgical procedures out of hernia repair
Date of first enrolment	14/01/2013
Date of final enrolment	28/05/2015

Locations

Countries of recruitment

Belgium

Study participating centre

Saint-Pierre University Hospital

Université Libre de Bruxelles
Department of Gastrointestinal Surgery
European School of Laparoscopic Surgery
322, Rue Haute
Brussels
1000
Belgium

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Giovanni Dapri (giovanni@dapri.net).

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2018		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

13/07/2018: Publication reference added.