Clinical trial NCT05230407: Does BMI Influence Pain Follow vNOTE Surgery
Official title: Does BMI Influence Pain Follow vNOTE Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obese
Surgery
Pain, Postoperative
Keywords: Obesity
Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES)
Post-operative pain
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women undergoing vNOTES for hysterectomy or adnexal indication

Brief 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.

Detailed 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

Eligibility criteria: 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)

Primary outcomes:
measure: Postoperative visual analogue scale (VAS) score
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Use of medication for pain control
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas
state: Texas
Study officials:
References:
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