The Effect of Staple Line Reinforcement Procedures on Postoperative Nausea and Vomiting in Sleeve Gastrectomy

NCT06151912 | Unknown DMC

• 1 other identifier: E-16214662-050.01.04-254590-62
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity is a significant public health problem. The only long-term effective treatment method is surgery. The most common surgical procedure is laparoscopic sleeve gastrectomy (LSG). However, after LSG, complications such as gastroesophageal reflux disease (GERD), insufficient weight loss, stenosis in the remnant stomach, and bleeding or leakage in the staple line (SL) may be encountered. The most severe complications are leakage and bleeding in sleeve gastrectomy, which can lead to many morbidities and mortality. Strengthening the staple line is an important option to prevent these complications. Methods such as fibrin adhesives, bioabsorbable patches and stitching of the stapler line are used to strengthen the stapler line. Nausea and vomiting, which occur in the postoperative period in 40% of patients who have undergone abdominal surgery and constitute a serious problem, are detected at an even higher rate in patients who have undergone bariatric surgery. Additionally, strengthening the staple line with various methods may increase the incidence of nausea and vomiting after LSG. Although there are studies in the literature investigating whether strengthening the staple line with buttress material or suture in laparoscopic sleeve gastrectomy affects the incidence of postoperative nausea and vomiting, there is no study investigating the effect of strengthening the staple line with fibrin glue on the incidence of postoperative nausea and vomiting. This prospective study aims to reveal whether there is a difference between strengthening the staple line with fibrin glue or suture in LSG regarding the incidence of postoperative nausea and vomiting and its effects on quality of life.

Conditions

Bariatric Surgical Procedures; Nausea, Postoperative; Vomiting, Postoperative

Outcome Measures

Primary Outcomes (8)

• Postoperative nausea and vomiting intensity scale (6. hours)

  Question 1. Have you vomited or had dry-retching? 1. No 0 point 2. Once or twice 2 point 3. Three or more times 50 points Question 2. Have you experienced a feeling of nausea? If yes, has your feeling interfered with being able to get out of bed, walking, eating or drinking? 1. No 0 point 2. Sometimes 1 point 3. Often or most of the time 2 point 4. All of the time 25 point Question 3. Has your nausea been mostly: 1. Varying ("comes and goes") 1point 2. Constant 2 point Question 4. What was the duration of your feeling of nausea (in hours)? …, … (hours). If the answer to Q1=c), score=50 Otherwise, select the highest score of Q1 or Q2, the multiply x Q3 x Q4 Postoperative nausea and vomiting intensity score:

  Postoperative 6 hours

• Postoperative nausea and vomiting intensity scale (24. hours)

  Question 1. Have you vomited or had dry-retching? 1. No 0 point 2. Once or twice 2 point 3. Three or more times 50 points Question 2. Have you experienced a feeling of nausea? If yes, has your feeling interfered with being able to get out of bed, walking, eating or drinking? 1. No 0 point 2. Sometimes 1 point 3. Often or most of the time 2 point 4. All of the time 25 point Question 3. Has your nausea been mostly: 1. Varying ("comes and goes") 1point 2. Constant 2 point Question 4. What was the duration of your feeling of nausea (in hours)? …, … (hours). If answer to Q1=c), score=50 Otherwise, select the highest score of Q1 or Q2, the multiply x Q3 x Q4 Postoperative nausea and vomiting intensity score:

  Postoperative 24 hours

• Postoperative nausea and vomits intensity scale (72. hours)

  Question 1. Have you vomited or had dry-retching? 1. No 0 point 2. Once or twice 2 point 3. Three or more times 50 points Question 2. Have you experienced a feeling of nausea? If yes, has your feeling interfered with being able to get out of bed, walking, eating or drinking? 1. No 0 point 2. Sometimes 1 point 3. Often or most of the time 2 point 4. All of the time 25 point Question 3. Has your nausea been mostly: 1. Varying ("comes and goes") 1point 2. Constant 2 point Question 4. What was the duration of your feeling of nausea (in hours)? …, … (hours). If answer to Q1=c), score=50 Otherwise, select the highest score of Q1 or Q2, the multiply x Q3 x Q4 Postoperative nausea and vomiting intensity score:

  Postoperative 72 hours

• Quality of life (index)

  The EuroQol Group (EQ-5D-5L) questionnaire will be used to evaluate quality of life. According to the survey, patients will be evaluated in five areas (mobility, self-care, usual activities, pain, and anxiety).

  Baseline (Index)

• Quality of life (24. hours)

  The EuroQol Group (EQ-5D-5L) questionnaire will be used to evaluate quality of life. According to the survey, patients will be evaluated in five areas (mobility, self-care, usual activities, pain, and anxiety).

  Postoperative 24 hours

• Quality of life (72. hours)

  The EuroQol Group (EQ-5D-5L) questionnaire will be used to evaluate quality of life. According to the survey, patients will be evaluated in five areas (mobility, self-care, usual activities, pain, and anxiety).

  Postoperative 72 hours

• Quality of life (1. month)

  The EuroQol Group (EQ-5D-5L) questionnaire will be used to evaluate quality of life. According to the survey, patients will be evaluated in five areas (mobility, self-care, usual activities, pain, and anxiety).

  Postoperative 1 month

• Postoperative nausea and vomiting intensity scale (1. month)

  Question 1. Have you vomited or had dry-retching? 1. No 0 point 2. Once or twice 2 point 3. Three or more times 50 points Question 2. Have you experienced a feeling of nausea? If yes, has your feeling interfered with being able to get out of bed, walking, eating or drinking? 1. No 0 point 2. Sometimes 1 point 3. Often or most of the time 2 point 4. All of the time 25 point Question 3. Has your nausea been mostly: 1. Varying ("comes and goes") 1point 2. Constant 2 point Question 4. What was the duration of your feeling of nausea (in hours)? …, … (hours). If answer to Q1=c), score=50 Otherwise, select the highest score of Q1 or Q2, the multiply x Q3 x Q4 Postoperative nausea and vomiting intensity score:

  Postoperative 1 month

Other Outcomes (3)

• Age

  1 day First application

• Body Mass Index (Index)

  1 day First application

• Body mass Index

  Postoperative 1 month

Study Arms (2)

Fibrin Glue Group

EXPERIMENTAL

Sleeve gastrectomy will be performed on morbidly obese patients, starting 3 cm cranial to the pylorus, under the guidance of a 36 F bougie. Then, Fibrin Glue (TisseelTM-Baxter, USA) will be applied to the staple line.

Other: Postoperative Nausea and Vomiting scala; Other: Quality of life

Suture Group

ACTIVE COMPARATOR

Sleeve gastrectomy will be performed on morbidly obese patients, starting 3 cm cranial to the pylorus, under the guidance of a 36 F bougie. Then, the stapler line will be sutured with continuous sutures with 3/0 prolene suture, with the stapler line inverted.

Other: Postoperative Nausea and Vomiting scala; Other: Quality of life

Interventions

Postoperative Nausea and Vomiting scala OTHER

The Nausea and Vomiting Intensity Scale will be used. Patients will be evaluated with this scale at 1, 6, 24 hours and one month. According to this scale, A total score of ≥50 at any time during the study period will be defined as clinically significant nausea and vomiting.

Fibrin Glue Group; Suture Group

Quality of life OTHER

The EuroQol Group (EQ-5D-5L) questionnaire will assess the quality of life in five domains (mobility, personal care, usual activities, pain and anxiety). A higher score indicates more excellent quality of life impairment. The survey will be administered to patients immediately before surgery and 24 hours and four weeks after surgery to establish baseline values.

Fibrin Glue Group; Suture Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a body mass index of 40 kg/m2 and above

You may not qualify if:

• Patients with hiatal hernia, gastritis or ulcer detected during endoscopy
• Smoker
• Patients who have previously had another bariatric procedure
• Patients who have previously undergone gastrointestinal system surgery
• Patients with any contraindications for bariatric surgery

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (1)

Sakarya University

Sakarya, Adapazarı, 54100, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• Ruiz-Tovar J, Zubiaga L, Munoz JL, Llavero C. Incidence of postoperative nausea and vomiting after laparoscopic sleeve gastrectomy with staple line reinforcement with oversewing and staple line inversion vs buttressing material: A randomized clinical trial. Int J Surg. 2018 Nov;59:75-79. doi: 10.1016/j.ijsu.2018.09.010. Epub 2018 Oct 3.

  PMID: 30292000 BACKGROUND

• Naeem Z, Nie L, Drakos P, Yang J, Gan TJ, Pryor AD, Spaniolas K. The Relationship Between Postoperative Nausea and Vomiting and Early Self-Rated Quality of Life Following Laparoscopic Sleeve Gastrectomy. J Gastrointest Surg. 2021 Aug;25(8):2107-2109. doi: 10.1007/s11605-021-04923-4. Epub 2021 Feb 2. No abstract available.

  PMID: 33528788 BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Quality of Life

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Central Study Contacts

Adem Yuksel, M.D

CONTACT

+905053455259; ademyuksel@sakarya.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Morbidly obese patients will undergo sleeve gastrectomy, starting 3 cm cranial to the pylorus, under the guidance of a 36 F bougie. After gastrectomy, fibrin glue will be applied to the stapler line in one of the groups. In the other group, the staple line will be sutured with 3/0 prolene in an inverted manner.

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 30, 2023
• Study Start: June 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: July 30, 2024
• Last Updated: November 30, 2023

Record last verified: 2023-11

Locations

TU (1)