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Inguinal HerniaNCT04628455

Needlescopic Inversion and Snaring of Hernia in Girls

A study testing Inversion and snaring in people with Inguinal Hernia and Polyps, run by Al-Azhar University at 2 sites in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Two Millimetres needlescopic instruments induce minimal damage to the abdominal wall and have excellent cosmetic results. However, these instruments are fragile and expensive with short weak jaws. Read more about this study

Who is it for?
Ages 6 months to 10 years, women only
Conditions the study is for
Inguinal Hernia, Polyps, Fallopian Tube Injury
What is being tested?
Inversion and snaring
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
2 sitesEgypt
Study dates
1 Apr 2018to 2 Jul 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 10 years
  • Women only
  • No healthy volunteers
  • Child

Who may be able to join

  • Bilateral congenital inguinal hernia Unilateral congenital inguinal hernia Hernia defect siameter less than 1.5 mm

Who cannot join

  • Recurrent hernia age less than 6 Month Contraindication to laparoscopy

Trial locations and contacts

2 sites in 1 country.

Egypt2 sites
  • Rafik Sahalaby

    Cairo

  • Rafik Shalaby

    Cairo

Other trials in Egypt

About this study

Official title: Needlescopic Inversion and Snaring for Inguinal Hernia in Girls Using 1.6-mm Instruments

Two Millimetres needlescopic instruments induce minimal damage to the abdominal wall and have excellent cosmetic results. However, these instruments are fragile and expensive with short weak jaws. The aim of this study is to present a novel needlescopic approach using 1.6-mm Suture Grasper Device [SGD], modified polypectomy snare and a home-made Snare (HMS) for the treatment of congenital inguinal hernias [CIH] in girls. Over a period of one year from March 2018 to March 2019 a prospective study was conducted in three tertiary centres on 53 girls presented with CIH. Preoperative inguinoscrotal U/S was done for all patients to confirm the diagnosis and to measure the diameter of internal inguinal ring [IIR]. All patients were repaired using needlescopic inversion and snaring of the hernia sac using 2-SGDs and a snare. Follow up period ranged from 12 to 24 (Median 16.5) months. Fifty-three girls with 74 hernias were included in this study. Their mean age was 37.8 months. Internal inguinal ring diameter (IIR) ranged between 8-15 mm with a mean of 11.8±2.8mm. Mean operative time was 15.5 minutes in bilateral and 11.4 minutes in unilateral cases. Mean operative time for inversion, snaring, and sac extraction was 4.2±1.3 minutes. All cases were completed successfully without conversion and without complications. Follow up period ranged from 12 to 24 (Median 16.5) months with non-visible scar and no recurrence among the studied patients. Needlescopic inversion and snaring of inguinal hernia using 1.6mm instruments is a safe, rapid and feasible method for CIH repair in girls with invisible scar and no short-term recurrence.

Read the detailed description

Operative details: Patient lies in supine position at upper part of OR table towards right edge. Operating table is tilted to opposite side of hernia with 30-degree Trendelenburg position. Operator stands on patient's right side during either uni-or bi-lateral hernia. Camera man stands at table head and monitor facing patient's feet. Vertical trans umbilical 5-mm incision [Point A] was made and 5-mm trocar passed under vision using open technique. Pneumoperitoneum is then established with CO2 flow of 1.5-2.5 L/min keeping intraabdominal pressure between 8-12 mmHg according to patients' age and weight. Early in our experience, a two-mm incision is done at a point located midway between umbilicus and symphysis pubis [point B] for 2-mm port passed under direct vision and a tiny 11-blade scalpel puncture was done at the corresponding Mac-Burney's [Point C] for SGD. Abdomen was then explored to confirm the diagnosis and detect contralateral or other hernias if present.

One SGD was introduced through point B (SGD-B) and another one through point C (SGD-C). Both SGDs were used to invert the hernia sac by gradual sustained alternating traction on the round ligament. Each SGD hands to the other one till complete inversion occurs, this is known by the hernial sac hanging from internal ring without retracting-back inside the inguinal canal. Occasionally, investigators had to fix the sac to the anterior abdominal wall by a suture [Prolne 2/0 on a half circle 20-mm needle] placed percutaneously lateral to the corresponding Mac-Berney's point to prevent its retraction. Then, the MPS was introduced via the trocar at point B and opened inside the abdomen and SGD-C passed inside the loop of MPS and re-catches the hernial sac, which is then twisted around its neck several times. MPS was closed tightly at the proper neck and coagulation diathermy current is applied to it leading to separation of the hernia sac. Detached sac (grasped by SGD-C) was then pushed antegradely out through the umbilical port. In some cases, the Fallopian's tube was closely related to the round ligament and investigators had to divide the round ligament with the long microdiathermy needle introduced directly via point B before hernia sac snaring to avoid its injury during the application of MPS. Deflation of the abdomen is done, and umbilical fascial incision is closed using 2/0 or 3/0 Polygalctin suture and umbilical skin layers were closed using 4/0 Polygalctin suture. Later in the study, we were able to innovate a HMS by using the guide wire of central venous catheter looped through VAC and connected to a regular diathermy probe and investigators modified our technique. An11-blade scalpel puncture is done at point-B through which VAC is introduced directly instead of 2-mm trocar. This VAC is used for the insertion of HMS and SGD-B. Then, complete inversion of the sac was done using 2 SGDs as previously described. Followed by introduction of HMS through #14-G VAC at point-B and the procedure completed as before.

Postoperative Management:

Patients received antibiotics and analgesics according to hospital protocols. Oral fluids started 2 hours post operatively and diet was advanced gradually as tolerated. Patients were discharged the same post-operative day. Follow up period ranged from 12 to 24 (Median 16.5) months. with for recurrence and cosmetic results.

Discussion:

In the last 2 decades, pediatric inguinal hernia repair witnessed a huge evolution with laparoscopic approaches attracting more and more pediatric surgeons and laparoscopic hernia repair became well-established and popular technique with comparable recurrence rates and operative time. Moreover, laparoscopy allows diagnosis of contralateral and other coexisting hernia with a chance for simultaneous repair. Early in the laparoscopic era, its drawbacks were long learning curve, need for smaller instruments for younger kids, higher recurrence rates, and to somewhat smaller but visible scars compared to conventional open hernia repair. With time, regular use of laparoscopy, fine instruments, introduction of newer concepts and techniques for tailoring which laparoscopic technique fits for each patient the results came to be similar or even better than that of conventional repair. Laparoscopy for female inguinal hernia repair was first introduced in 1997 by El Gohary. He described hernial sac inversion and ligation in girls using 5-mm instruments and endo loop with excellent results.

During the evolution of laparoscopic repair of hernia, results improved very much by cautery of the IIR enhancing peritoneal fibrosis hence reducing recurrence rates compared to simple peritoneal closure.

Snaring is routinely used for colonic polypectomy with excision of polyps at its proper neck using coagulation current without colonic wall perforation. In this study it is proposed that inversion and snaring of the hernia sac results in a herniotomy with narrow raw area at its neck of the hernia sac combining the benefits of both peritoneal disconnection and thermal injury to prevent recurrence. Recently there is a report of early results of inversion, and snaring of hernial sac using 3-mm instruments and commercial polypectomy snare in girls with encouraging results and no recurrence. On application of monopolar diathermy current to the snare itself, the hernial sac will shrink with almost closure of internal ring. No recurrence was reported with no perioperative complications except for lymphocele developed at the level of labium major 2 weeks postoperatively that completely resolved after 6 months.

Commercially available polypectomy snare length is 230-cm which imposed discomfort and difficulty using it for hernial sac snaring. So, investigators opted to shorten it from 230-cm to 50 cm to facilitate its usage. The biomedical engineering department was contacted and succeeded to shorten it to the required length. In this study, in the first 2 months investigator used this modified snare successfully but it is still not fully satisfied as it adds extra cost [needs 2-mm trocar for insertion], needs technical assistance for shortening and re-sterilization. Investigator came into another innovation by developing a home-made snare (HMS) made of central venous catheter guide wire looped through VAC and connected to a regular diathermy probe. Each wire can be cut to make 2-3 snares. It is shorter, easy to use, cheaper and avoided the use of expensive trocar 2-mm. This HMS was then applied for all upcoming cases after that. It is well known that, one of the most annoying factors lead to delayed acceptance of laparoscopic repair for CIH among pediatric surgeons is visible scars even though they are smaller compared to the hidden skin crease scar of the open repair which ultimately resulted in development of needlescopic repair. Chock et al. reported that despite good cosmetic results, 2-mm instruments are expensive, delicate, flexible, and with short and weak jaws limiting their use on a wide scale. Others reported that needlescopic instruments can be used only by expert surgeons as it can be bended easily and its small jaws limit the power of grasping the tissue with unsuitability for ideal retraction and tissue handling. In contrary, SGD used for port closure is only 1.6 mm in diameter with adequate length, strong shaft, ergonomic handle, cheap, wide jaw and offers a very good tissue grip. According to the results of this study, needlescopic inversion, snaring and complete excision of the hernia is a progress of minilaparoscopic surgery where two MSDs [1.6-mm diameter] were used instead of 2-3-mm instruments for the treatment of CIH in girls. It avoids the disadvantages of 2-mm instruments.

Being tested
Inversion and snaring
Medical subject headings
Hernia, Inguinal, Polyps, Congenital Abnormalities

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inversion and snaringDevice

    Vertical umbilical 5-mm incision was made for 5-mm trocar. Pneumoperitoneum is then established with CO2 flow of 1.5-2.5 L/min keeping intraabdominal pressure between 8-12 mmHg. A two-mm incision was done at a point B [midway between umbilicus and symphysis pubis] for 2-mm port passed under direct vision and a tiny 11-blade scalpel puncture is done at the corresponding Mac-Burney's [Point C] for SGD.

    Both SGDs were used to invert the hernia sac by gradual sustained alternating traction on the round ligament. Each SGD hands to the other one till complete inversion occurs, this is known by the hernial sac hanging from internal ring without retracting-back inside the inguinal canal. Then, the MPS is introduced via 2-mm trocar at point. SGD-C passed inside the loop of MPS and re-catches the hernial sac, which is then twisted around its neck several times. MPS was closed at the neck and diathermy current is applied. Detached sac was then pushed antigradely out through the umbilical port.

Study groups in NCT04628455
Study groupRoleWhat they receive
Inversion and SnaringOtherneedlescopic inversion, snaring, and excision of the hernia sac using two Suture Grasper Sevice of Mediflex Company and a home made snare
Receives: Device: Inversion and snaring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrence of Hernia

    All patients were examined clinical and by U/S for detection of the recurrence

    Measured: every month up to one year postoperative

Secondary outcomes (1)
  1. Operative time

    The operative time will be measured by minutes from the start of skin incision to the end of operation

    Measured: every minute up to 2 hours (the end of the surgery)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2020
  2. Study start1 Apr 2018
  3. Primary completion2 Jun 2019
  4. Study completion2 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Both SGDs were used to invert the hernia sac by gradual sustained alternating traction on the round ligament. Each SGD hands to the other one till complete inversion occurs, this is known by the hernial sac hanging from internal ring without retracting-back inside the inguinal canal. . SGD-C passed inside the loop of MPS and re-catches the hernial sac, which is then twisted around its neck several times. MPS is closed tightly at the proper neck and coagulation diathermy current is applied.Detached sac was then pushed antigradely out through the umbilical port.
Masking
None (open label)
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04628455
Sponsor's protocol ID
PS2020-1002
Status last verified
Nov 2020
First submitted
15 May 2020
Last updated
13 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • McClain L, Streck C, Lesher A, Cina R, Hebra A. Laparoscopic needle-assisted inguinal hernia repair in 495 children. Surg Endosc. 2015 Apr;29(4):781-6. doi: 10.1007/s00464-014-3739-8. Epub 2014 Aug 9.

    PubMed 25106720
  • Schier F. Laparoscopic herniorrhaphy in girls. J Pediatr Surg. 1998 Oct;33(10):1495-7. doi: 10.1016/s0022-3468(98)90483-3.

    PubMed 9802799
  • Wang K, Cai J, Lu YC, Li XW, Zhai GM, He WB, Guo XS, Wu GQ. A Faster and Simpler Operation Method for Laparoscopic Inguinal Hernia Repair in Children. J Laparoendosc Adv Surg Tech A. 2020 Jun;30(6):706-711. doi: 10.1089/lap.2019.0598. Epub 2020 Mar 27.

    PubMed 32216722
  • Kantor N, Travis N, Wayne C, Nasr A. Laparoscopic versus open inguinal hernia repair in children: which is the true gold-standard? A systematic review and meta-analysis. Pediatr Surg Int. 2019 Sep;35(9):1013-1026. doi: 10.1007/s00383-019-04521-1. Epub 2019 Jul 10.

    PubMed 31292721
  • Chan IH, Tam PK. Laparoscopic Inguinal Hernia Repair in Infants and Children: State-of-the-Art Technique. Eur J Pediatr Surg. 2017 Dec;27(6):465-471. doi: 10.1055/s-0037-1608685. Epub 2017 Nov 22. No abstract available.

    PubMed 29166678
  • Gause CD, Casamassima MGS, Yang J, Hsiung G, Rhee D, Salazar JH, Papandria D, Pryor HI 2nd, Stewart D, Lukish J, Colombani P, Chandler NM, Johnson E, Abdullah F. Laparoscopic versus open inguinal hernia repair in children </=3: a randomized controlled trial. Pediatr Surg Int. 2017 Mar;33(3):367-376. doi: 10.1007/s00383-016-4029-4. Epub 2016 Dec 26.

    PubMed 28025693
  • Barroso C, Etlinger P, Alves AL, Osorio A, Carvalho JL, Lamas-Pinheiro R, Correia-Pinto J. Learning Curves for Laparoscopic Repair of Inguinal Hernia and Communicating Hydrocele in Children. Front Pediatr. 2017 Sep 27;5:207. doi: 10.3389/fped.2017.00207. eCollection 2017.

    PubMed 29021976
  • Zallen G, Glick PL. Laparoscopic inversion and ligation inguinal hernia repair in girls. J Laparoendosc Adv Surg Tech A. 2007 Feb;17(1):143-5. doi: 10.1089/lap.2006.0553.

    PubMed 17362194
  • Guner YS, Emami CN, Chokshi NK, Wang K, Shin CE. Inversion herniotomy: a laparoscopic technique for female inguinal hernia repair. J Laparoendosc Adv Surg Tech A. 2010 Jun;20(5):481-4. doi: 10.1089/lap.2009.0169.

    PubMed 20367121
  • Xi HW, Duan WQ, Cui QQ, You ZH, Zhao Z, Zhang P. Transumbilical Single-Site Laparoscopic Inguinal Hernia Inversion and Ligation in Girls. J Laparoendosc Adv Surg Tech A. 2015 Jun;25(6):522-5. doi: 10.1089/lap.2014.0383. Epub 2015 May 5.

    PubMed 25941750
  • Ostlie DJ, Ponsky TA. Technical options of the laparoscopic pediatric inguinal hernia repair. J Laparoendosc Adv Surg Tech A. 2014 Mar;24(3):194-8. doi: 10.1089/lap.2014.0081.

    PubMed 24625350
  • Lipskar AM, Soffer SZ, Glick RD, Rosen NG, Levitt MA, Hong AR. Laparoscopic inguinal hernia inversion and ligation in female children: a review of 173 consecutive cases at a single institution. J Pediatr Surg. 2010 Jun;45(6):1370-4. doi: 10.1016/j.jpedsurg.2010.02.113.

    PubMed 20620347
  • Chen YN, Chang LC, Chang CY, Chen PJ, Chen CY, Tseng CH, Chiu HM. Comparison of cold and hot snaring polypectomy for small colorectal polyps: study protocol for a randomized controlled trial. Trials. 2018 Jul 6;19(1):361. doi: 10.1186/s13063-018-2743-z.

    PubMed 29980220
  • Blatnik JA, Harth KC, Krpata DM, Kelly KB, Schomisch SJ, Ponsky TA. Stitch versus scar--evaluation of laparoscopic pediatric inguinal hernia repair: a pilot study in a rabbit model. J Laparoendosc Adv Surg Tech A. 2012 Oct;22(8):848-51. doi: 10.1089/lap.2012.0137. Epub 2012 Sep 18.

    PubMed 22989037
  • Shalaby R, Elsaied A, Shehata S, Shehata S, Hamed A, Alsamahy O, Ashour Y, Elsayaad I, Shahin M. Needlescopic assisted internal ring suturing; a novel application of low-cost home-made instruments for pediatric inguinal hernia repair. Hernia. 2019 Dec;23(6):1279-1289. doi: 10.1007/s10029-019-01982-0. Epub 2019 May 25.

    PubMed 31129795

Questions about this trial

What is this clinical trial studying?

A study testing Inversion and snaring in people with Inguinal Hernia and Polyps, run by Al-Azhar University at 2 sites in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence of Hernia (time frame: every month up to one year postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04628455, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.

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