A study of pain following laparoscopic ventral hernia mesh repair.
- Conditions
- Ventral hernia without obstructionor gangrene,
- Registration Number
- CTRI/2021/01/030678
- Lead Sponsor
- Lady Hardinge Medical College
- Brief Summary
**Introduction**: Laparoscopic repair with use of mesh remains the procedure of choice for all ventral hernias.Laparoscopic intra-peritoneal onlay mesh (IPOM) technique which involves placement of appropriate size prosthesis inside the peritoneal cavity with (IPOM Plus) or without (standard IPOM) closure of fascial defect continue to remain the most popular choice among hernia surgeons because of its safety and effectiveness with low recurrence rate.
However concern remain regarding the post-operative pain with use of fixation, high cost of surgery with the use of expensive coated mesh and tackers and also with long term risk of intra-abdominal adhesions as potential complication with mesh inside the peritoneal cavity.
Several methods of laparoscopic mesh placement outside the peritoneal cavity are gaining prominence as potential alternatives to IPOM.
To tackle the large groin hernia enhanced view-totally extraperitoneal technique (eTEP) was first described by Jorge Daes in 2012 and lately it has been applied to ventral hernias by Belyansky et al with promising results.
The eTEP involves developing of retro muscular space by minimally invasive surgical technique with placement of mesh as suggested by Rives and Stoppa . The theoretical benefits of eTEP over IPOM approach are less post-operative pain because of extra-peritoneal position with non-fixation of mesh, reduced total cost of surgery with use of less expensive non coated mesh without the need for tackers and reduced risk of potential complications related to intra-peritoneal placement of mesh like injury to abdominal viscera’s and risk of intra-abdominal adhesions. The disadvantages of eTEP repair over IPOM are less working space, unfamiliar anatomy and the need for extensive dissection making it technically difficult and time consuming with overall long learning curves for most of the surgeons.
Although there has been recent increase in popularity of laparoscopic eTEP technique for ventral hernia patients with many recent published literature supporting eTEP technique as a safe and effective in treatment of ventral hernia patients. While most of these studies are retrospective and or lack control arm, we plan to perform RCT between laparoscopic eTEP and IPOM technique in patients with small to medium size midline ventral hernia to have an evidence-based answer to early post-operative pain and intra-operative surgeon work load.
**AIMS AND OBJECTIVES**
**REASEARCH QUESTION**
Whether the patients with midline ventral hernia undergoing laparoscopic eTEP mesh repair experience less post-operative pain as compared to patients undergoing repair by laparoscopic IPOM technique ?
**RESEARCH HYPOTHESIS**
Patients with midline ventral hernia undergoing laparoscopic eTEP mesh repair experience a 30% decrease in pain scores by postoperative day one as compared to patients undergoing repair by laparoscopic IPOM technique.
**NULL HYPOTHESIS**
There is no difference in postoperative day one pain scores between patients with midline ventral hernia undergoing laparoscopic eTEP mesh repair as compared to patients undergoing repair by laparoscopic IPOM technique.
**AIM**
To determine early post-operative pain and intraoperative surgeon workload following midline ventral hernia repair by laparoscopic eTEP mesh repair and repair by laparoscopic IPOM technique.
**PRIMARY OBJECTIVE**
To determine early post-operative pain following midline ventral hernia repair by laparoscopic eTEP mesh repair and repair by laparoscopic IPOM technique.
**SECONDARY OBJECTIVE**
1. To determine Operative time
2. To determine intraoperative surgeon workload
**MATERIALS AND METHODS**
• **Study type:** Interventional study
• **Study design:** Randomized Control Trial (RCT) Superior
Allocation : Randomized
Intervention Model: Parallel Assignment
Masking : Single (Participant)
Primary Purpose: Intention to treat
• **Period of Study:** January 2021 to June 2022
• **Place of Study:** Department of General Surgery, Lady Hardinge Medical College and Associated Hospitals {Smt. Sucheta Kriplani Hospital (SSKH) New Delhi and Ram Manohar Lohia Hospital (RMLH) New Delhi} New Delhi-110001
• **Approval:** Institutional Ethic Committee, LHMC New Delhi.
University study board (University of Delhi, New Delhi)
• **Study population:** Adult patients (18-65 years) with diagnosis of primary ventral or incisional hernia presenting to surgery OPD of Lady Hardinge Medical College and Associated Hospitals (SSKH and RMLH) New Delhi.
• **Sample size:** Adjusted total sample size required 60, with 30 patients in each in study and comparator arm respectively.
***Inclusion criteria:*** The following criteria of selection will be adhered to:
• Adult patients with age between 18-65 years.
• Patients having uncomplicated primary ventral or incisional hernial defects.
• Midline defect with expected hernial width equal to or less than 10cm.
***Exclusion criteria:*** The following exclusion criteria will be adopted in this study:
• Patients with multiple defects.
• Patient with associated groin hernia.
• Patients with recurrent ventral hernia following prior mesh repair.
• Patients who failed to understand NRS-11 scale.
**METHODS**
Adult patients of either gender presenting to the Surgery OPD at Lady Hardinge Medical College and associated Hospitals (SSKH and RMLH) New Delhi with complaints suggestive of reducible midline abdominal wall swellings will be clinically evaluated for features of ventral hernia.
After the diagnosis of midline ventral hernia is established by clinical and or radiological teste as and when required the patient will be assessed as per pre-defined above mentioned inclusion and exclusion criteria’s and those who will meet the study criteria will be enrolled after obtaining well informed written consent.
A total of 60 subject will be enrolled , 30 in each study arm and will undergo laparoscopic ventral hernia mesh repair according to assigned treatment arm. The study will consist of two interventions : Experimental arm ( Laparoscopic eTEP mesh repair), Comparator arm ( Laparoscopic IPOM repair).
All the subject will be explained in details about the purpose of study, consent will be taken for both the procedures without disclosure of assigned group to participant.
All surgeries will be performed by expert laparoscopic surgeons with more than ten years of experience in the field of advance laparoscopy with special interest and experience in laparoscopic hernia surgeries at Lady Hardinge Medical College & associated Hospitals New Delhi India.
The subject will be assigned to either arm using block randomization with block size of four. A computer based randomization plan will be generated from [www.randomization.com](http://www.randomization.com/) and assigned arm of each subject will be disclosed to operating surgeon in operation room (OR).
**OBSERVATIONS:**
**1.****Pain on post-operative day-1**
Pain will be assessed by Numeric Pain Rating Scale (NRS-11) on post-operative day one.
The NRS is an 11-point scale comprising a number from 0 through 10; 0 indicates “no painâ€, and 10 indicates the “worst imaginable painâ€. Patients will be instructed to choose a single number from the scale that best indicates their level of pain.
**2.****Total operative time**
The total operating time in minutes will be calculated from the time of skin incision for first port (eTEP repair) or Verees insertion (IPOM repair) till skin closure of all ports.
3. **Intra-operative surgeon work load**
Surgeon workload will be quantified by using a modified version of validated Surgical Task Load Index (SURG-TLX) questionnaire with the addition of question from Global Operative Assessment of Laparoscopic Skills (GOALS) to increase its relevance to measuring intraoperative workload. This consist of self-reported scales rating an individual’s mental demand, physical demand, task complexity, distractions and degree of difficulty. The resulting questionnaire will be administered to operating surgeon immediately after surgical procedure.
**PRIMARY OUTCOME:**
Post-operative pain
Mean NRS-11 score on post op day one between two groups.
**SECONDARY OUTCOME:**
1. Total operative time
Mean total operative time in minutes between two groups.
2. Intra-operative surgeon work load
As asses by using a modified version of validated Surgical Task Load Index (SURG-TLX) questionnaire between two groups.
**STATISTICAL ANALYSIS:**
All the observations will be recorded on the proforma. These observations will be analyzed using the available statistical package. Continuous variables will be compared using student t test. Categorical variables will be compared with chi-square test or Fisher’s exact test. Values of p<0.05 will be considered statistically significant.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
- 1 Patients having uncomplicated primary ventral or incisional hernial defects.
- 2 Midline defect with expected hernial width equal to or less than 10cm.
- •Patients with multiple defects.
- •Patient with associated groin hernia.
- •Patients with recurrent ventral hernia following prior mesh repair.
- •Patients who failed to understand NRS-11 scale.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Early post-operative pain Post operative pain in first 24 hours
- Secondary Outcome Measures
Name Time Method Intraoperative surgeon workload At base line Operative time At baseline
Trial Locations
- Locations (1)
Lady Hardinge Medical College
🇮🇳Central, DELHI, India
Lady Hardinge Medical College🇮🇳Central, DELHI, IndiaDr Anil ChaudharyPrincipal investigator7014054067anilchoudhary.ac.in@gmail.com