Wrapping of the appendix stump by the omentum reduces pain and speeds recovery after removal of the appendix
| ISRCTN | ISRCTN89363255 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89363255 |
- Submission date
- 26/07/2023
- Registration date
- 07/08/2023
- Last edited
- 20/02/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Pain control after laparoscopic (keyhole) surgeries is a major concern. Many factors contribute to pain after laparoscopic appendectomy (removal of the appendix). Researchers have devised a method to reduce pain after laparoscopic appendectomy by wrapping the cecum (the beginning of the large intestine) with the appendix stump by the greater omentum (the fatty tissue that drapes over the intestines) during laparoscopic appendectomy. This study aims to investigate the effectiveness of this method.
Who can participate?
Patients aged over 18 years with appendicitis
What does the study involve?
Participants are randomly allocated to laparoscopic appendectomy with omental wrapping or traditional laparoscopic appendectomy. Postoperative pain and analgesics use are measured. The researchers also recorded operation time, time to pass gas, white blood cells count, C- reactive protein (CRP) on second postoperative day, postoperative nausea, frequency of antiemetic medications, and length of hospital stay.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
National Jeddah Hospital (Saudi Arabia)
When is the study starting and how long is it expected to run for?
May 2020 to June 2023
Who is funding the study?
National Jeddah Hospital (Saudi Arabia)
Who is the main contact?
Maged Rihan, m.rihan@njchospital.com
Contact information
Scientific
National Jeddah Hospital
CairoJeddah
21472
Saudi Arabia
 ORCID ID |
0000-0001-9323-9405 |
|---|---|
| Phone | +966 (0)596519744 |
| m.rihan@njchospital.com |
Study information
| Study design | Single-center prospective single-blinded randomized controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Omental wrapping of the cecum and appendix stump reduces postoperative pain and speeds recovery after laparoscopic appendectomy: a prospective randomized controlled trial |
| Study objectives | Wrapping the cecum and the appendix stump by the greater omentum at the end of laparoscopic appendectomy, could minimize postoperative pain and speeds recovery for patients after laparoscopic appendectomy. |
| Ethics approval(s) |
Approved 30/04/2020, Jeddah National Hospital Research Ethics Board (Medina Square, PO Box 7697, Jeddah, 21400, Saudi Arabia; 7675000; jnchospital@jnchospital.com), ref: 20.43 |
| Ethics approval additional information | Transposition of the omentum over the injured organ or tissue is a common surgical procedure. It can be done by simple placing and fixation on the desired site. It has been used to circumvent around the sites of the intestinal anastomosis to strengthen it, and to prevent leakage. |
| Health condition(s) or problem(s) studied | Acute appendicitis |
| Intervention | Randomization was done using the computational random number generator method. The evaluators for patients and pain were blinded to the details of the appendectomy operation. The traditional and wrapping groups underwent stratification-randomization in a 1:1 ratio. In all study patients, laparoscopic appendectomy was done. In the second group, at the end of the procedure, mobilization of the distal part of the greater omentum, and placing it over the cecum to cover the appendix stump to act as an insulator between the stump and the parietal peritoneum, using one or two resorbable tacks to fix the lower surface of the omentum to the peritoneal folds or appendices epiploicae of the cecum and not to the cecal wall itself. In the end, the inflation pressure is gradually decreased, while ensuring that the omentum remains within the scope of vision until it is confirmed that it is in the same place until the abdomen is completely emptied and becomes completely adherent to the parietal peritoneum. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Degree of postoperative intraabdominal (visceral) pain intensity evaluated by visual analogue scale (VAS) at the first 24 hours, between 24 and 48 hours, and 48 to 72 hours following the operation 2. Analgesics administration in the form of parenteral nonsteroidal anti-inflammatory drugs (NSAIDs) measured using the mean number of analgesic doses following surgery at the first 24 hours, and after 24 hours following the operation |
| Secondary outcome measures | 1. Operation time measured using time in medical records (minutes) at one timepoint 2. Time to pass gas measured using time in medical records (hours) at one timepoint 3. White blood cell count measured using standard laboratory testing (×103/μL count) and preoperative, and＞24 and＜48 hours following surgery 4. C-reactive protein (CRP) measured using standard laboratory testing (mg/L) on the second postoperative day 4. Postoperative nausea measured using a numerical rating scale at ＜24 hours, ＞24 and＜48 hours, and ＞48 and ＜72 hours following surgery 5. Frequency of antiemetic medications measured using the mean number of doses recorded following surgery at ＜24 hours, ＞24 and＜48 hours, and ＞48 and ＜72 hours following surgery 6. Length of hospital stay measured using time in medical records (days) at one timepoint |
| Overall study start date | 01/04/2020 |
| Completion date | 30/06/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 106 |
| Key inclusion criteria | 1. Patients aged more than 18 years 2. Diagnosed with acute appendicitis by clinical examination, ultrasonography, or CT scan |
| Key exclusion criteria | 1. Patients with complicated appendicitis by perforation or abscess formation 2. Pregnant women 3. Surgical technique was changed (conversion to open laparotomy, or further surgery was done) 4. Intraoperative finding of short omentum 5. Drainage tube was placed 6. Patient could not distinguish between intra-abdominal pain and pain originating from abdominal wounds 7. Patient expressed desire to terminate the study |
| Date of first enrolment | 01/06/2020 |
| Date of final enrolment | 30/05/2023 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
21472
Saudi Arabia
Sponsor information
Hospital/treatment centre
Jeddah
Jeddah
21472
Saudi Arabia
| Phone | +966 (0)6675000 |
|---|---|
| njchospital@njchospital.com |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 30/08/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets analysed during the study will be available upon request from Maged Rihan (magedrihan@hotmail.com) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 12/01/2024 | 20/02/2024 | Yes | No |
Editorial Notes
20/02/2024: Publication reference added.
07/08/2023: Trial's existence confirmed by the Jeddah National Hospital Research Ethics Board (Saudi Arabia).
