A Comparative Study on Trans-umbilical Single-port Laparoscopic Extra-peritoneal Approach Versus Conventional Repair for Inguinal Hernia in Children

NCT02960529 | Unknown DMC

• 1 other identifier: ZunyiMC
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Inguinal hernia is a common disease in children. Treatment of this disease by laparoscopic high ligation of the hernia sac has been accepted by domestic and foreign scholars. Since laparoscopic inguinal hernia was introduced in 1990,it has now become the most commonly performed hernia repair in children. The conventional approach this is done with2small trocars to 1trocar . however the wound complications of infection and pain and the recurrent rate have not been resolved. The aim of the study was to described a new way of extra-peritoneal high ligation of hernia sac. This method combines the single-port laparoscopic could eliminated rate of wound complications and recurrence in inguinal hernia repair in children. The investigators hoped that this study will prove that the extra-peritoneal single-port laparoscopic repair is at least a s effective and efficient as the conventional technique in the cure of inguinal hernia and may results in lower recurrence and reduce incidence of wound complications.

Conditions

Inguinal Hernia,Laparoscopy,Extra-peritoneal

Outcome Measures

Primary Outcomes (1)

• conversion to intraabdominal high ligation of inguinal hernia

  this study is to determine whether extra-peritoneal single-port laparoscopic repair for inguinal hernia in children is superior to conventional repair approaches.

  during operation

Secondary Outcomes (5)

• operating time

  during operation

• length of hospital time

  day procedure or overnight stay

• post operative pain scores

  preop, day one and day 7 postop

• recurrence of inguinal herina

  1 year

• post-operation complications including wound infection,stitch abscess, spermatic cord injuries,testicular atrophy.

  6 weeks

Study Arms (2)

extra-peritoneal high ligation of hernia

the 150 patients were subjected trans-umbilical single-port laparoscopic extra-peritoneal approach repair for inguinal hernia

Procedure: extra-peritoneal high ligation of hernia

intraabdominal high ligation of hernia

the 150 patients were subjected trans-umbilical single-port laparoscopic intraabdominal approach repair for inguinal hernia

Procedure: intraabdominal high ligation of hernia

Interventions

extra-peritoneal high ligation of hernia PROCEDURE

extra-peritoneal high ligation of hernia

intraabdominal high ligation of hernia PROCEDURE

intraabdominal high ligation of hernia

Eligibility Criteria

• Age: 6 Months - 13 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

All patients between 6 months and 13 years undergoing trans-umbilical single-port laparoscopic approach repair for inguinal hernia at our institution. half of patients undergoing extra-peritoneal andthe others undergoing intraabdominal.

You may qualify if:

• unilateral inguinal herina age between 6 months and 13 years no history of abdominal or inguinal operations of male patients ,only those with completely descended testes were included

You may not qualify if:

• the bilateral heina the recurrence herina

Sponsors & Collaborators

• zebing Zheng: lead

Study Sites (1)

Affiliated hospital of ZunYi medical college

Zunyi, Guizhou, 563000, China

RECRUITING

Related Publications (4)

• Jun Z, Juntao G, Shuli L, Li L. A comparative study on trans-umbilical single-port laparoscopic approach versus conventional repair for incarcerated inguinal hernia in children. J Minim Access Surg. 2016 Apr-Jun;12(2):139-42. doi: 10.4103/0972-9941.169953.

  PMID: 27073306 BACKGROUND

• Wolak PK, Patkowski D. Laparoscopic inguinal hernia repair in children using the percutaneous internal ring suturing technique - own experience. Wideochir Inne Tech Maloinwazyjne. 2014 Mar;9(1):53-8. doi: 10.5114/wiitm.2014.40389. Epub 2014 Jan 30.

  PMID: 24729810 BACKGROUND

• Blanco FC, Kane TD. Single-port laparoscopic surgery in children: concept and controversies of the new technique. Minim Invasive Surg. 2012;2012:232347. doi: 10.1155/2012/232347. Epub 2012 Jun 12.

  PMID: 22778945 BACKGROUND

• Lukong CS. Surgical techniques of laparoscopic inguinal hernia repair in childhood: a critical appraisal. J Surg Tech Case Rep. 2012 Jan;4(1):1-5. doi: 10.4103/2006-8808.100343.

  PMID: 23066453 BACKGROUND

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Zebing Zheng, MD

CONTACT

8618285269257; 674013289@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Affiliated hospital of Zunyi medical college

Study Record Dates

• First Submitted: November 7, 2016
• First Posted: November 9, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: December 1, 2017
• Last Updated: November 9, 2016

Record last verified: 2016-11

Locations

CN (1)