Does BMI Influence Pain Follow vNOTE Surgery

Surgery Clinical Trial

— BMIVNOTES  

Official title:

Does BMI Influence Pain Follow vNOTE Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05230407
• Other study ID #: BMIVNOTES-UT
• Status: Recruiting
• Start date: February 5, 2022
• Est. completion date: May 18, 2024

Study information

• Verified date: May 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Aya Mohr-Sasson, M.D
• Phone: 3462704682
• Email: mohraya[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Overweight and obesity are increasing dramatically worldwide and contribute substantially to the burden of morbidity and mortality. Obesity was considered in the past a relative contraindication for abdominal and pelvic laparoscopy surgeries due to the morbidity that is associated with it. Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) is an emerging field in minimally invasive surgery. By incorporating the advantages of endoscopic surgery, the vNOTES approach avoids abdominal wall wounds and trocar-related complications, including reducing post operation pain.

Description:

Introduction

Overweight and obesity are increasing dramatically worldwide and contribute substantially to the burden of morbidity and mortality. The clinical guidelines from the National Heart, Lung, and Blood Institute on the identification, evaluation, and treatment of overweight and obesity in adults recommend that clinicians assess waist circumference of their patients. In concordance to the increase in the prevalence of obesity, waist circumference also has shifted, and a rapid increase in abdominal obesity has been demonstrated.

Obesity was considered in the past a relative contraindication for abdominal and pelvic laparoscopy surgeries due to the morbidity that is associated with it. The major challenges include the difficulty with Verres needle placement, hindered manipulation of laparoscopic instruments, and the accumulation of fat in the omentum that often obstructs the operative field. In addition to complicated anesthesia characterizing obese patients due to reduced supine functional residual capacity, lower chest wall compliance, and increase in carbon dioxide production, pneumoperitoneum created during laparoscopic surgeries adds to increased inspiratory resistance that requires higher minute ventilation rates. Post-operative abdominal pain must be well controlled and avoided because it can further restrict ventilation and prevent ambulation.

Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) is an emerging field in minimally invasive surgery. By incorporating the advantages of endoscopic surgery, the vNOTES approach avoids abdominal wall wounds and trocar-related complications, including reducing post operation pain. Surgical outcomes of total laparoscopic hysterectomy (TLH) and vNOTES hysterectomy in obese patients are in favor for the vNOTES approach considering shorter duration of surgery and postoperative hospitalization, and lower pain scores .

To the best of our knowledge no studies have been published regarding the correlation between BMI to the pain experienced by women following vNOTE surgery. Due to the aforementioned, the aim of our study is to learn whether BMI influence pain following vNOTES.

Material and Methods This is a prospective cohort study conducted in a single tertiary medical center. Study population will include all women planned to undergo vNOTE surgery (hysterectomy or adnexal surgery). Women with previous vaginal operations or combined operations for the treatment of prolapse or urinary complains will be excluded from the study. Demographic and clinical characteristics will be collected from women's medical files. Additionally, operative and post-operative data will be collected including: operation duration, estimated blood loss, operation complications (hypotension, bladder gut or vascular perforation), post-operative complications (hemorrhage, endometritis, vascular - thromboembolic event, ileus).

Primary outcome:

Postoperative visual analogue scale (VAS). Evaluation will be performed before discharge or 24th post operation.

Secondary outcomes:

• Operative and post-operative complication rate

• Operative time

• Pill count

• Time until release

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 18, 2024
• Est. primary completion date: May 18, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Women undergoing vNOTES for hysterectomy or adnexal indication Exclusion Criteria.

• Previous vaginal operation

• Combined current vaginal operation (for the treatment of prolapse/ urinary complaints)

Related Conditions & MeSH terms

• Obese
• Pain, Postoperative
• Surgery

Intervention

Other:
• Visual analog scale (VAS) assesment of pain
Post operation VAS score will be assessed before discharge from hospital and 24 hours post operation

Locations

Country	Name	City	State
United States	University of Texas	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

References & Publications (9)

Baekelandt J, De Mulder PA, Le Roy I, Mathieu C, Laenen A, Enzlin P, Weyers S, Mol BW, Bosteels JJ. Postoperative outcomes and quality of life following hysterectomy by natural orifice transluminal endoscopic surgery (NOTES) compared to laparoscopy in wom — View Citation

Baekelandt JF, De Mulder PA, Le Roy I, Mathieu C, Laenen A, Enzlin P, Weyers S, Mol B, Bosteels J. Hysterectomy by transvaginal natural orifice transluminal endoscopic surgery versus laparoscopy as a day-care procedure: a randomised controlled trial. BJOG — View Citation

Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults--The Evidence Report. National Institutes of Health. Obes Res. 1998 Sep;6 Suppl 2:51S-209S. No abstract available. Erratum In: Obes Res 1998 Nov;6(6): — View Citation

Jallad K, Walters MD. Natural Orifice Transluminal Endoscopic Surgery (NOTES) in Gynecology. Clin Obstet Gynecol. 2017 Jun;60(2):324-329. doi: 10.1097/GRF.0000000000000280. — View Citation

Kaya C, Yildiz S, Alay I, Aslan O, Aydiner IE, Yasar L. The Comparison of Surgical Outcomes following Laparoscopic Hysterectomy and vNOTES Hysterectomy in Obese Patients. J Invest Surg. 2022 Apr;35(4):862-867. doi: 10.1080/08941939.2021.1927262. Epub 2021 — View Citation

Lamvu G, Zolnoun D, Boggess J, Steege JF. Obesity: physiologic changes and challenges during laparoscopy. Am J Obstet Gynecol. 2004 Aug;191(2):669-74. doi: 10.1016/j.ajog.2004.05.077. — View Citation

Le Bras M, Ribou G, Brachet-Liermain M. [Does mefloquine concentrate in the parasited red cell?]. Presse Med. 1989 Mar 4;18(9):492. No abstract available. French. — View Citation

Mokdad AH, Ford ES, Bowman BA, Dietz WH, Vinicor F, Bales VS, Marks JS. Prevalence of obesity, diabetes, and obesity-related health risk factors, 2001. JAMA. 2003 Jan 1;289(1):76-9. doi: 10.1001/jama.289.1.76. — View Citation

Must A, McKeown NM. The Disease Burden Associated with Overweight and Obesity. 2012 Aug 8. In: Feingold KR, Anawalt B, Blackman MR, Boyce A, Chrousos G, Corpas E, de Herder WW, Dhatariya K, Dungan K, Hofland J, Kalra S, Kaltsas G, Kapoor N, Koch C, Kopp P — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative visual analogue scale (VAS) score	Score is scaled between 1(no pain at all) to 10(very strong pain)	24 hours after surgery
Secondary	Use of medication for pain control	The type of medication and the number of pills used	24 hours after surgery