ObeseBMIVNOTESNCT05230407
Does BMI Influence Pain Follow vNOTE Surgery
An observational study of Obese and Surgery, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obese, Surgery, Pain, Postoperative
- What is being tested?
- Visual analog scale (VAS) assesment of pain
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2022to 18 May 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women undergoing vNOTES for hysterectomy or adnexal indication
Who may be able to join
- Women undergoing vNOTES for hysterectomy or adnexal indication Exclusion Criteria.
- Previous vaginal operation
- Combined current vaginal operation (for the treatment of prolapse/ urinary complaints)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Obese, Surgery, Pain, Postoperative
- Being tested
- Visual analog scale (VAS) assesment of pain
- Keywords
- Obesity, Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES), Post-operative pain
- Medical subject headings
- Obesity, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual analog scale (VAS) assesment of painOther
Post operation VAS score will be assessed before discharge from hospital and 24 hours post operation
| Study group | Role | What they receive |
|---|---|---|
| Women after Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) | Study population will include all women after hysterectomy or adnexal surgery by vNOTE technique Receives: Other: Visual analog scale (VAS) assesment of pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative visual analogue scale (VAS) score
Score is scaled between 1(no pain at all) to 10(very strong pain)
Measured: 24 hours after surgery
Secondary outcomes (1)
Use of medication for pain control
The type of medication and the number of pills used
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start5 Feb 2022
- Primary completion18 May 2024
- Study completion18 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for ObeseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Mohr Sasson, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05230407
- Sponsor's protocol ID
- BMIVNOTES-UT
- Acronym
- BMIVNOTES
- Status last verified
- Nov 2024
- First submitted
- 27 Dec 2021
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared upon author request
Publications
Must A, McKeown NM. The Disease Burden Associated with Overweight and Obesity. 2012 Aug 8. In: Feingold KR, Adler RA, Ahmed SF, Anawalt B, Blackman MR, Chrousos G, Corpas E, de Herder WW, Dhatariya K, Dungan K, Hamilton E, Hofland J, Jan de Beur S, Kalra S, Kaltsas G, Kapoor N, Kim M, Koch C, Kopp P, Korbonits M, Kovacs CS, Kuohung W, Laferrere B, Levy M, McGee EA, McLachlan R, Muzumdar R, Purnell J, Rey R, Sahay R, Shah AS, Sperling MA, Stratakis CA, Trence DL, Wilson DP, editors. Endotext [Internet]. South Dartmouth (MA): MDText.com, Inc.; 2000-. Available from http://www.ncbi.nlm.nih.gov/books/NBK279095/
PubMed 25905320Mokdad 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.
PubMed 12503980Clinical 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.
PubMed 9813653Le 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.
PubMed 2522648Lamvu 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.
PubMed 15343262Jallad 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.
PubMed 28221179Baekelandt 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 women with a non-prolapsed uterus and benign gynaecological disease: a systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2017 Jan;208:6-15. doi: 10.1016/j.ejogrb.2016.10.044. Epub 2016 Oct 29.
PubMed 27880893Baekelandt 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. 2019 Jan;126(1):105-113. doi: 10.1111/1471-0528.15504.
PubMed 30325565Kaya 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 May 26.
PubMed 34036898
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does BMI Influence Pain Follow vNOTE Surgery
- ClinicalTrials.gov ID
- NCT05230407
- Acronym / sponsor ID
- BMIVNOTES / BMIVNOTES-UT
- Conditions
- Obese, Surgery, Pain, Postoperative
- Keywords
- Obesity, Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES), Post-operative pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 5 Feb 2022 (actual)
- Primary completion
- 18 May 2024 (actual)
- Study completion
- 18 May 2024 (actual)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women after Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) | – | Other: Visual analog scale (VAS) assesment of painStudy population will include all women after hysterectomy or adnexal surgery by vNOTE technique |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women undergoing vNOTES for hysterectomy or adnexal indication
Key inclusion criteria (3 listed)
- Women undergoing vNOTES for hysterectomy or adnexal indication Exclusion Criteria.
- Previous vaginal operation
- Combined current vaginal operation (for the treatment of prolapse/ urinary complaints)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual analog scale (VAS) assesment of painPost operation VAS score will be assessed before discharge from hospital and 24 hours post operation | Other | Women after Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) |
Primary outcome
Postoperative visual analogue scale (VAS) score
Time frame: 24 hours after surgery
Score is scaled between 1(no pain at all) to 10(very strong pain)
1 secondary outcome
Use of medication for pain control
Time frame: 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Results publication: PubMed 25905320Must A, McKeown NM. The Disease Burden Associated with Overweight and Obesity. 2012 Aug 8. In: Feingold KR, Adler RA, Ahmed SF, Anawalt B, Blackman MR, Chrousos G, Corpas E, de Herder WW, Dhatariya K, Dungan K, Hamilton E, Hofland J, Jan de Beur S, Kalra S, Kaltsas G, Kapoor N, Kim M, Koch C, Kopp P, Korbonits M, Kovacs CS, Kuohung W, Laferrere B, Levy M, McGee EA, McLachlan R, Muzumdar R, Purnell J, Rey R, Sahay R, Shah AS, Sperling MA, Stratakis CA, Trence DL, Wilson DP, editors. Endotext [Internet]. South Dartmouth (MA): MDText.com, Inc.; 2000-. Available from http://www.ncbi.nlm.nih.gov/books/NBK279095/
- Results publication: PubMed 12503980Mokdad 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.
- Results publication: PubMed 9813653Clinical 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.
- Results publication: PubMed 2522648Le 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.
- Results publication: PubMed 15343262Lamvu 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.
- Results publication: PubMed 28221179Jallad 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.
- Results publication: PubMed 27880893Baekelandt 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 women with a non-prolapsed uterus and benign gynaecological disease: a systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2017 Jan;208:6-15. doi: 10.1016/j.ejogrb.2016.10.044. Epub 2016 Oct 29.
- Results publication: PubMed 30325565Baekelandt 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. 2019 Jan;126(1):105-113. doi: 10.1111/1471-0528.15504.
- Results publication: PubMed 34036898Kaya 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 May 26.
- Individual participant dataSharing planned: Undecided. Data will be shared upon author request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obese and Surgery, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative visual analogue scale (VAS) score (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05230407, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.