Gastric Decompression for Gynecologic Surgery

No longer recruiting at 1 trial location

Overseen By Adaeze Emeka, MB BCh BAO

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Gastric reflux, Peptic ulcer, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: At time of surgery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates the necessity of decompressing the stomach during gynecologic laparoscopic surgery, a minimally invasive procedure. Researchers aim to determine whether not decompressing affects the surgical view, increases the risk of stomach injury, and impacts recovery. Participants will either undergo gastric decompression with a tube or not and will log their recovery for a week after surgery. The trial seeks individuals undergoing gynecologic laparoscopy for procedures such as hysterectomy, pelvic pain, or tumor removal. As an unphased trial, it offers participants the chance to contribute to medical knowledge and potentially enhance surgical outcomes.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications, so it's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that gastric decompression is safe for gynecologic surgery?

Research has shown that using a tube to relieve pressure in the stomach, known as gastric decompression, is generally safe. One study found that an orogastric tube, inserted through the mouth to the stomach, wasn't always necessary, yet the procedure was rated as "excellent" or "good" in 69% of cases without it. A review of 37 studies found that routinely using a nasogastric tube, inserted through the nose to the stomach, might not speed recovery after abdominal surgery and could be safely omitted in some cases.

Importantly, the data suggest that these tubes do not pose a serious risk. One report found no deaths linked to using a gastric decompression tube. This indicates that while the procedure is generally safe, its necessity might depend on the specific situation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about investigating gastric decompression in gynecologic surgery because it could offer a new approach to managing post-operative care. Unlike standard procedures that often do not involve gastric decompression, this method involves placing a nasogastric or orogastric tube after intubation to potentially improve patient outcomes. By using this technique, researchers hope to maintain surgical blinding while reducing complications like nausea or abdominal discomfort after surgery. This may enhance recovery time and patient comfort, making it an innovative addition to gynecologic surgical protocols.

What evidence suggests that gastric decompression is effective for gynecologic surgery?

This trial will compare the use of gastric decompression with no gastric decompression during gynecologic surgeries. Research has shown that using a tube to empty the stomach during these surgeries might not be necessary. One study found that 69% of surgeries achieved "excellent" or "good" results without this tube. Additionally, a review of several studies found that using a nasogastric tube (a tube through the nose into the stomach) after surgery did not speed up patient recovery. Specifically, for patients with gynecologic cancers, this tube did not improve recovery. These findings suggest that omitting stomach decompression might be as effective as using it during surgery. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals scheduled for gynecologic laparoscopy, including procedures like hysterectomy and surgery on ovaries or fallopian tubes. Surgeons involved range from general to specialized gynecologists. Participants must follow standard recovery protocols and are willing to log their post-surgery experience.

Inclusion Criteria

I am having a laparoscopy for a gynecological reason like surgery or to diagnose a condition.

I am scheduled for gynecologic surgery for conditions like tumors, pelvic pain, or diagnostic reasons.

My surgery will be done by a specialized gynecologic surgeon.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo their planned gynecologic laparoscopy with or without gastric decompression

At time of surgery

1 visit (in-person)

Post-operative Monitoring

Participants complete a log about their recovery for the first week after surgery

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of post-operative complications

Up to 6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Gastric decompression

Trial Overview The study tests if stomach decompression during gynecologic laparoscopy is necessary. It compares the surgical view, risk of stomach injury, and patient recovery between those with and without this procedure.

How Is the Trial Designed?

Group I: Gastric decompression Experimental Treatment 1 Intervention

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.

Group II: No gastric decompression Active Control 1 Intervention

No placement of gastric decompression tube.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Published Research Related to This Trial

A study involving 119 patients with gastric adenocarcinoma found no significant difference in postoperative complications between those who underwent surgery without nasogastric decompression (tubeless group) and those who had it (intubated group), indicating that surgery can be safely performed without the tube.

The time to pass flatus and length of hospital stay were similar for both groups, further supporting the idea that nasogastric decompression may not be necessary in gastric cancer surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of gastric cancer surgery with versus without nasogastric decompression. Lee, JH., Hyung, WJ., Noh, SH.[2006]

In a study involving 31 patients who had extensive intraabdominal urological surgery, performing a gastrostomy for gastric decompression was found to be safe, with no complications during the procedure.

All patients tolerated the gastrostomy well, indicating it is a viable alternative to nasogastric tubes for gastric decompression, with two patients even being fed through the gastrostomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Gastrostomy instead of gastric intubation for stomach decompression after large urologic operations]. van Adrichem, NP., van Leewaarden, B., Vos, P., et al.[2006]

Nasogastric suction is a common method for gastric decompression due to its simplicity, but it can cause significant discomfort and complications, particularly in vulnerable populations like the young, elderly, and smokers.

Temporary gastrostomy may be a safer alternative for prolonged decompression, as it is associated with fewer complications compared to nasogastric suction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relative merits of temporary gastrostomy and nasogastric suction of the stomach. Ochsner, A.[2019]

In a study of 110 gynecologic oncology patients, postoperative nasogastric tube decompression did not significantly improve recovery outcomes compared to orogastric tube decompression, as both groups had similar times to regular diet tolerance and hospital stays.

However, the nasogastric group experienced significantly more discomfort, including ear pain and painful swallowing, and had a higher incidence of febrile morbidity, leading to the conclusion that nasogastric decompression should be avoided in most cases post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of postoperative nasogastric tube decompression in gynecologic oncology patients undergoing intra-abdominal surgery. Pearl, ML., Valea, FA., Fischer, M., et al.[2009]

In a study of 174 gastric cancer patients, those with a nasogastric decompression tube experienced significantly lower rates of postoperative symptoms like nausea and sore throat compared to those without the tube.

However, patients without the nasogastric tube had quicker recovery times for ambulation and flatus, suggesting that early removal of the tube is safe and can enhance the quality of life during hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Value of nasogastric decompression tube in patients with gastric cancer]. Yu, XF., Wei, YZ., Xue, YW.[2012]

In a study of 136 gastric cancer patients undergoing radical gastrectomy, those who did not receive routine nasogastric decompression experienced significantly shorter recovery times, including faster passage of flatus and earlier resumption of a liquid diet.

There were no significant differences in postoperative complications or mortality between the groups, suggesting that routine nasogastric decompression may not be necessary for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nasogastric decompression is not necessary in operations for gastric cancer: prospective randomised trial. Yoo, CH., Son, BH., Han, WK., et al.[2022]

Early oral feeding after elective colorectal surgery is safe, with no significant differences in nausea or vomiting rates compared to traditional feeding methods, indicating that it can be a viable option for postoperative care.

Despite the safety of early feeding, the study found no significant reduction in the length of hospital stay between patients who received early feeding and those who followed traditional feeding protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early postoperative feeding after elective colorectal surgery. Hartsell, PA., Frazee, RC., Harrison, JB., et al.[2022]

In a study of 519 patients undergoing radical gastric surgery, routine nasogastric (NG) decompression did not significantly reduce the rate of anastomotic leaks, suggesting it may not be necessary for these patients.

Patients who underwent Roux-en-Y reconstruction without NG decompression had a shorter time to start a semi-liquid diet and a lower rate of postoperative pneumonia compared to those with NG decompression or Billroth II reconstruction, indicating better recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Roux-en-Y reconstruction does not require gastric decompression after radical distal gastrectomy. Chen, CJ., Liu, TP., Yu, JC., et al.[2021]

A study involving 162 cholecystectomy patients found that nasogastric decompression does not significantly reduce complications like nausea or vomiting compared to patients who did not receive decompression.

Patients who did not undergo nasogastric decompression experienced faster recovery, requiring less parenteral support and being discharged earlier, suggesting that the routine use of decompression is unnecessary and may delay recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NASOGASTRIC DECOMPRESSION IN CHOLECYSTECTOMY, IS IT NECESSARY? Mehrotra, S., Patnaik, PK.[2020]

In a study of 66 patients who underwent elective transvaginal surgery with pylorectomy, those who did not have gastric decompression (ND group) or had short-term nasogastric suction (NGS group) experienced shorter hospital stays compared to those with a tube gastrostomy (G group).

The NGS group faced a higher rate of mechanical complications when the nasogastric tube was in place for more than 48 hours, suggesting that routine gastric decompression is unnecessary and that short-term suction is preferable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of gastric decompression after truncal vagotomy and anterior pylorectomy. Sitges-Serra, A., Cabrol, J., Gubern, JM., et al.[2009]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06137976

Surgeon Perception of Gastric Decompression at Time ... The goal of this clinical trial is to test whether it is necessary to decompress the stomach during gynecologic laparoscopy.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1553465025003607

Safe without Suction: RCT Challenges Routine Gastric ... Stomach decompression was rated “excellent” or “good” in 69% of cases without orogastric tube placement. The stomach was adequately decompressed in 100% of ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6669251/

Prophylactic nasogastric decompression after abdominal ... This systematic review of 37 trials showed that routine use of nasogastric tube decompression after abdominal operations, rather than speeding recovery, may ...

4. withpower.com withpower.com/trial/phase-postoperative-complications-10-2023-9e5d4

Gastric Decompression for Gynecologic Surgery In a study of 110 gynecologic oncology patients, postoperative nasogastric tube decompression did not significantly improve recovery outcomes compared to ...

5. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/398215

Nasogastric Intubation After Abdominal Surgery: A Meta- ... Secondary outcomes were GI function, time to first peristaltic movements, passage of flatus, passage of stools, liquid and regular diet, ...

6. apm.amegroups.org apm.amegroups.org/article/view/128076/html

Cervical gastric decompression tube: safety and efficacy ... The 30-day mortality rate after the procedure was 9%. Importantly, no deaths were associated with CEG tube placement. Data indicating the efficacy of CEG tubes ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4088090/

Early removing gastrointestinal decompression and ... The data from the present study not only confirmed that placement of a nasogastric tube can be safely omitted in colorectostomy but also demonstrated that ...