| CTRI Number |
CTRI/2012/09/003007 [Registered on: 20/09/2012] Trial Registered Retrospectively |
| Last Modified On: |
06/09/2012 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of different methods of performing laparoscopic inguinal hernia repair |
|
Scientific Title of Study
|
A Comparison Of Chronic Groin Pain And Quality Of Life after Totally Extrapertoneal (TEP) And Transabdominal Preperitoneal (TAPP) Laparoscopic Inguinal Hernia Repair- a prospective randomized controlled study |
| Trial Acronym |
TEP vs TAPP RCT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Virinder Kumar Bansal |
| Designation |
Additional Professor of Surgery |
| Affiliation |
All India Institute of Medical Sciences, New Delhi, India |
| Address |
Room No. 5021,
Department of Surgical Disciplines,
AIIMS, Ansari Nagar, New Delhi-110029
South
DELHI
110029
India |
| Phone |
01126593686 |
| Fax |
01126588324 |
| Email |
drvkbansal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh C Misra |
| Designation |
Professor and Head of Surgery |
| Affiliation |
All India Institute of Medical Sciences, New Delhi, India |
| Address |
Room No. 5031,
Department of Surgical Disciplines,
AIIMS, Ansari Nagar, New Delhi-110029
South
DELHI
110029
India |
| Phone |
01126594776 |
| Fax |
01126588324 |
| Email |
mcmisra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jonathan Victor |
| Designation |
Junior resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi, India |
| Address |
Department of Surgical Disciplines,
AIIMS, Ansari Nagar, New Delhi-110029
South
DELHI
110029
India |
| Phone |
01126593686 |
| Fax |
01126588324 |
| Email |
jonathanvctr@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
Ansari Nagar, new delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Virinder Kumar Bansal |
All India Institute of Medical Sciences, New Delhi, India |
Department of Surgical Disciplines,
AIIMS, Ansari Nagar, New Delhi-110029
South
DELHI |
01126593686
01126588324
drvkbansal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA 1/2 pateints with primary inguinal hernia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Laparoscopic inguinal hernia repair, comparison of Totally Extraperitoneal Repair, with Transabdominal Preperitoneal Repair |
Laparoscopic inguinal hernia repair, comparison of Totally Extraperitoneal Repair, with Transabdominal Preperitoneal Repair |
| Comparator Agent |
Laparoscopic totally extraperitoneal(TEP) repair of groin hernia group I |
TEP repair would be done and compared in terms of QOL and chronic groin pain |
| Comparator Agent |
Laparoscopic Transperitoneal (TAPP)repair of groin hernia will be done in Group II |
TAPP repair would be done and compared in terms of QOL and chronic groin pain |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All consecutive patients clinically diagnosed with uncomplicated symptomatic inguinal hernias were included in the study |
|
| ExclusionCriteria |
| Details |
Patients were excluded if there was
(i) Co-morbid conditions making the patients unfit for general anesthesia
(ii) Complicated hernias (irreducibility)
(iii) Uncorrectable coagulopathy
(iv) Suspected intra-abdominal or pelvic malignancy
(v) Significant co-morbidities like hypertension, bronchial asthma, diabetes or any other systemic disease likely to delay the recovery of the patient.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of chronic groin pain and quality of life after transabdominal preperitoneal (TAPP) and totally exptraperitoneal (TEP) techniques of laparoscopic inguinal hernia repair |
Patients were followed up at 1 and 6 weeks, 3, 6, 12 and 18 months and yearly thereafter |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study and compare the possible factors responsible for chronic groin pain after transabdominal preperitoneal (TAPP) and totally exptraperitoneal (TEP) techniques of laparoscopic inguinal hernia repair |
Patients were followed up at 1 and 6 weeks, 3, 6, 12 and 18 months and yearly thereafter |
|
|
Target Sample Size
|
Total Sample Size="314"
Sample Size from India="314"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/11/2009 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Ready for publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Background
To
compare TEP and TAPP techniques of laparoscopic inguinal hernia repair and
evaluate the factors related to chronic groin pain and the long term quality of
life.
Materials
and Methods
262 patients with
groin hernia were randomized either to transabdominal preperitoneal (TAPP) or
totally exptraperitoneal (TEP) techniques of laparoscopic inguinal hernia
repair. Intra-operative details and postoperative complications were recorded. Pain
was assessed with Visual analogue scale(VAS) preoperatively and postoperatively at 24 hours,
1 week, 6 weeks; 3, 6 and 12 months and yearly thereafter. Quality of life was assessed in 162 patients with
Short Form – 36 version 2 (SF 36v2) preoperatively and postoperatively at 3
months follow up.
Results
The demographic and clinical profiles
were well matched in both the groups. Both TEP and TAPP
techniques were comparable in terms of intaoperative complications and early
postoperative outcomes. In the present study patients experienced significantly
higher incidence of acute pain following TAPP repair (p=0.001), however the
incidence of chronic groin pain was comparable in both TEP and TAPP techniques (p=0.683).
Pre-operative pain, and immediate postoperative pain at 24 hours were found to
be associated with chronic groin pain. Improvement from preoperative to 3
months postoperative was demonstrated in all domains in TEP group and this was
statistically highly significant. In the TAPP group significant improvement was
seen in the domains of physical functions, role physical, bodily pain, general
health, role emotional and mental health. This significant improvement in
quality of life mirrors less chronic pain and early return to normal activity
after both the laparoscopic repairs i.e. TEP and TAPP.
Both TEP and TAPP groups were comparable in terms of quality of life outcomes
in the postoperative period.
Conclusion
There was no
difference in late outcomes of chronic groin pain and quality of life after TEP
or TAPP repair. Preoperative pain and
pain in the immediate postoperative period 24 hours after surgery were found to
be significant risk factors for chronic groin pain. |