Surgeon Perception of Gastric Decompression at Time of Gynecologic Laparoscopy

NCT06137976 | Completed

• 1 other identifier: STU00219580
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to test whether it is necessary to decompress the stomach during gynecologic laparoscopy. The main questions it aims to answer are:

• Is there appropriate visualization during surgery without stomach decompression?
• Can the surgeon tell the stomach is decompressed?
• Is the stomach at risk for injury during surgery?
• How is the patient's postoperative experience affected? Participants will undergo their planned surgery as usual and will be asked to complete log about their recovery for the first week after surgery. Researchers will compare patients who have their stomach decompressed during surgery to those who do not undergo stomach decompression to see if it is necessary.

Conditions

Gynecologic Surgical Procedures; Gastric Injury; Aspiration; Nausea, Postoperative; Postoperative Complications; Enhanced Recovery After Surgery; Laparoscopy

Keywords

Gastric decompression; Gynecologic surgery; Gynecologic laparoscopy; Surgical visualization; Enhanced Recovery After Surgery

Outcome Measures

Primary Outcomes (2)

• Adequate gastric decompression

  The primary endpoint is the percentage of cases rated as adequate decompression by the surgeon.

  At time of surgery

• Gastric injury

  The primary safety endpoint is the estimated negligible rate of gastric injury.

  Up to six weeks post-operatively

Secondary Outcomes (6)

• Presence of gastric decompression tube

  At time of surgery

• Gastric injury risk assessment

  At time of surgery

• Degree of stomach decompression

  At time of surgery

• Entry proximity

  At time of surgery

• Post-operative experience questionnaire

  First 7 days after surgery

Study Arms (2)

Gastric decompression

EXPERIMENTAL

Placement of the nasogastric or orogastric tube will occur after intubation while surgeons are scrubbing and out of the room to maintain blinding. At the end of surgery, the nasogastric or orogastric tube will be removed prior to removal of the surgical drapes to ensure the surgeon remains blinded. Patients will then be returned to routine post-operative care as otherwise planned or necessitated by surgery.

Procedure: Gastric decompression (oropharyngeal or nasopharyngeal gastric tube)

No gastric decompression

NO INTERVENTION

No placement of gastric decompression tube.

Interventions

Gastric decompression (oropharyngeal or nasopharyngeal gastric tube) PROCEDURE

Placement of tube through the nose or mouth into the stomach for gastric decompression

Gastric decompression

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing gynecologic laparoscopy for the following indications: hysterectomy, adnexal surgery, benign and malignant tumors or disease, diagnostic purposes, lysis of adhesions, and pelvic pain.
• Surgery being performed by gynecologic surgeon with or without minimally invasive gynecologist certification, gynecologic oncologists, urogynecologists, and reproductive endocrinologists.

You may not qualify if:

• Entry sites other than umbilical
• Planned or high suspicion for bowel surgery
• Anticipated surgical time \>4 hours
• Known diagnosis of gastric reflux disease or peptic ulcer disease
• Prior history of gastric or esophageal surgery excluding endoscopy
• Day of surgery emesis events
• Difficult intubation determined by anesthesia
• Intrauterine pregnancy
• Chronic lung disease
• Individuals with smoking history.
• Individuals who do not speak English due to limitations in ability to reliably obtain informed consent in their primary language.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (2)

259 E Erie - Northwestern

Chicago, Illinois, 60611, United States

Location

Prentice Women'S Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (18)

• Berkow, L. Rapid sequence induction and intubation (RSII) for anesthesia. UpToDate, 2023. https://www.uptodate.com/contents/rapid-sequence-induction-and-intubation-rsii-for-anesthesia

  BACKGROUND

• Cheatham ML, Chapman WC, Key SP, Sawyers JL. A meta-analysis of selective versus routine nasogastric decompression after elective laparotomy. Ann Surg. 1995 May;221(5):469-76; discussion 476-8. doi: 10.1097/00000658-199505000-00004.

  PMID: 7748028 BACKGROUND

• Chui PT, Gin T, Oh TE. Anaesthesia for laparoscopic general surgery. Anaesth Intensive Care. 1993 Apr;21(2):163-71. doi: 10.1177/0310057X9302100205.

  PMID: 8517506 BACKGROUND

• Coskun F. Anesthesia for gynecologic laparoscopy. J Am Assoc Gynecol Laparosc. 1999 Aug;6(3):245-58. doi: 10.1016/s1074-3804(99)80057-7.

  PMID: 10459023 BACKGROUND

• Feldheiser A, Aziz O, Baldini G, Cox BP, Fearon KC, Feldman LS, Gan TJ, Kennedy RH, Ljungqvist O, Lobo DN, Miller T, Radtke FF, Ruiz Garces T, Schricker T, Scott MJ, Thacker JK, Ytrebo LM, Carli F. Enhanced Recovery After Surgery (ERAS) for gastrointestinal surgery, part 2: consensus statement for anaesthesia practice. Acta Anaesthesiol Scand. 2016 Mar;60(3):289-334. doi: 10.1111/aas.12651. Epub 2015 Oct 30.

  PMID: 26514824 BACKGROUND

• Hodin, R. Inpatient placement and management of nasogastric and nasoenteric tubes in adults. UpToDate, 2023. https://www.uptodate.com/contents/inpatient-placement-and-management-of-nasogastric-and-nasoenteric-tubes-in-adults

  BACKGROUND

• Hu H, Choi JDW, Edye MB, Aitken T, Kapurubandara S. Gastric Injury at Laparoscopy for Gynecologic Indications: A Systematic Review. J Minim Invasive Gynecol. 2022 Nov;29(11):1224-1230. doi: 10.1016/j.jmig.2022.09.058. Epub 2022 Sep 30.

  PMID: 36184063 BACKGROUND

• Manning BJ, Winter DC, McGreal G, Kirwan WO, Redmond HP. Nasogastric intubation causes gastroesophageal reflux in patients undergoing elective laparotomy. Surgery. 2001 Nov;130(5):788-91. doi: 10.1067/msy.2001.116029.

  PMID: 11685187 BACKGROUND

• Michowitz M, Chen J, Waizbard E, Bawnik JB. Abdominal operations without nasogastric tube decompression of the gastrointestinal tract. Am Surg. 1988 Nov;54(11):672-5.

  PMID: 3190004 BACKGROUND

• Nelson R, Edwards S, Tse B. Prophylactic nasogastric decompression after abdominal surgery. Cochrane Database Syst Rev. 2007 Jul 18;2007(3):CD004929. doi: 10.1002/14651858.CD004929.pub3.

  PMID: 17636780 BACKGROUND

• Nelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for pre- and intra-operative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations--Part I. Gynecol Oncol. 2016 Feb;140(2):313-22. doi: 10.1016/j.ygyno.2015.11.015. Epub 2015 Nov 18. No abstract available.

  PMID: 26603969 BACKGROUND

• Nelson G, Bakkum-Gamez J, Kalogera E, Glaser G, Altman A, Meyer LA, Taylor JS, Iniesta M, Lasala J, Mena G, Scott M, Gillis C, Elias K, Wijk L, Huang J, Nygren J, Ljungqvist O, Ramirez PT, Dowdy SC. Guidelines for perioperative care in gynecologic/oncology: Enhanced Recovery After Surgery (ERAS) Society recommendations-2019 update. Int J Gynecol Cancer. 2019 May;29(4):651-668. doi: 10.1136/ijgc-2019-000356. Epub 2019 Mar 15.

  PMID: 30877144 BACKGROUND

• Rao W, Zhang X, Zhang J, Yan R, Hu Z, Wang Q. The role of nasogastric tube in decompression after elective colon and rectum surgery: a meta-analysis. Int J Colorectal Dis. 2011 Apr;26(4):423-9. doi: 10.1007/s00384-010-1093-4. Epub 2010 Nov 24.

  PMID: 21107848 BACKGROUND

• Scheib SA, Thomassee M, Kenner JL. Enhanced Recovery after Surgery in Gynecology: A Review of the Literature. J Minim Invasive Gynecol. 2019 Feb;26(2):327-343. doi: 10.1016/j.jmig.2018.12.010. Epub 2018 Dec 20.

  PMID: 30580100 BACKGROUND

• Schwartz KM, Wright KN, Richards EG, King LP, Park AJ. Sustainability in Healthcare: A Call to Action for Surgeons and Healthcare Leaders. J Minim Invasive Gynecol. 2022 Sep;29(9):1040-1042. doi: 10.1016/j.jmig.2022.06.024. Epub 2022 Jul 1. No abstract available.

  PMID: 35788396 BACKGROUND

• Siedhoff MT, Clark LH, Hobbs KA, Findley AD, Moulder JK, Garrett JM. Mechanical bowel preparation before laparoscopic hysterectomy: a randomized controlled trial. Obstet Gynecol. 2014 Mar;123(3):562-567. doi: 10.1097/AOG.0000000000000121.

  PMID: 24499763 BACKGROUND

• Stone R, Carey E, Fader AN, Fitzgerald J, Hammons L, Nensi A, Park AJ, Ricci S, Rosenfield R, Scheib S, Weston E. Enhanced Recovery and Surgical Optimization Protocol for Minimally Invasive Gynecologic Surgery: An AAGL White Paper. J Minim Invasive Gynecol. 2021 Feb;28(2):179-203. doi: 10.1016/j.jmig.2020.08.006. Epub 2020 Aug 20.

  PMID: 32827721 BACKGROUND

• ACOG Committee Opinion No. 750 Summary: Perioperative Pathways: Enhanced Recovery After Surgery. Obstet Gynecol. 2018 Sep;132(3):801-802. doi: 10.1097/AOG.0000000000002819.

  PMID: 30134419 RESULT

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Postoperative Complications

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: * Patient will masked to group assignment and will be under anesthesia during intervention. * Surgeon will be masked to group assignment. Placement of the nasogastric or orogastric tube will occur while the surgeon is scrubbing and out of the room. There will be a drape over the face until the surgical drapes are covering the patient to maintain surgeon blinding. Removal of tube will take place prior to undraping the patient to maintain blinding. * All documents noted group assignment will be in an opaque envelope.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Minimally Invasive Gynecologic Surgery

Model Details: * Block randomization in groups of 10 to either receive nasogastric or orogastric intubation after endotracheal intubation prior to abdominal entry for the duration of the surgery or no gastric decompression at all. * Sequentially numbered, opaque, sealed envelope (SNOSE) technique

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 18, 2023
• Study Start: November 20, 2023
• Primary Completion: March 17, 2025
• Study Completion: April 28, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)