Gastric Decompression for Gynecologic Surgery

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

150 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of gastric decompression as a treatment for gynecologic surgery?

Research suggests that nasogastric decompression (using a tube to remove stomach contents) after extensive intra-abdominal surgery in gynecologic oncology patients may not be necessary, as it does not significantly improve recovery and can lead to complications if used for more than 48 hours. ^{1 2 3 4 5}

Is gastric decompression safe for humans?

Research shows that gastric decompression, whether through gastrostomy or nasogastric intubation, is generally safe for humans. Studies indicate no significant complications during procedures, and patients tolerate them well. ^{3 6 7 8 9}

How is gastric decompression different from other treatments for gynecologic surgery?

Gastric decompression, often done using a nasogastric tube (a tube inserted through the nose into the stomach), is unique because it helps relieve pressure in the stomach after surgery, which can reduce discomfort and complications. Unlike other methods, it is non-invasive and can be easily applied, although it may cause more discomfort compared to alternatives like gastrostomy (a surgical opening into the stomach). ^{1 3 6 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Roux-en-Y reconstruction does not require gastric decompression after radical distal gastrectomy. [2021]

2. China pubmed.ncbi.nlm.nih.gov

[Value of nasogastric decompression tube in patients with gastric cancer]. [2012]

3. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of postoperative nasogastric tube decompression in gynecologic oncology patients undergoing intra-abdominal surgery. [2009]

4. United States pubmed.ncbi.nlm.nih.gov

A randomized trial of gastric decompression after truncal vagotomy and anterior pylorectomy. [2009]

5. England pubmed.ncbi.nlm.nih.gov

Nasogastric decompression is not necessary in operations for gastric cancer: prospective randomised trial. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

[Gastrostomy instead of gastric intubation for stomach decompression after large urologic operations]. [2006]

7. United States pubmed.ncbi.nlm.nih.gov

Early postoperative feeding after elective colorectal surgery. [2022]

8. India pubmed.ncbi.nlm.nih.gov

NASOGASTRIC DECOMPRESSION IN CHOLECYSTECTOMY, IS IT NECESSARY? [2020]

9. Korea (South) pubmed.ncbi.nlm.nih.gov

Comparison of gastric cancer surgery with versus without nasogastric decompression. [2006]

10. United States pubmed.ncbi.nlm.nih.gov

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