NCT02687412

Fast-track Surgery After Gynecological Oncology Surgery

Completed NA Results posted Last updated 26 September 2019

What this trial tests

NA trial testing pre-operative assessment, counseling and education in Length of Stay in 107 participants. Completed in 21 March 2018.

Timeline

21 November 2016

Primary endpoint
2 September 2017

21 March 2018

Quick facts

Lead sponsor	Ling Cui
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	107
Start date	21 November 2016
Primary completion	2 September 2017
Estimated completion	21 March 2018
Sites	1 location across China

Drugs / interventions tested

• pre-operative assessment, counseling and education
• Preoperative nutritional drink up to 4 h prior to surgery
• bowel preparation — full drug profile →
• preoperative treatment with carbohydrates
• fast solid
• avoiding hypothermia
• Postoperative glycaemic control
• postoperative nausea and vomiting (PONV) control;
• early postoperative diet
• pre-operative fasting at least 8h
• bowel preparation for traditional surgery
• began to take solid diet after anal exhaust

Conditions studied

• Length of Stay — all drugs for Length of Stay →
• Postoperative Complications — all drugs for Postoperative Complications →
• CRP — all drugs for CRP →

Sponsor

Ling Cui

Who can join

Adults 18 to 70, female only, with Length of Stay or Postoperative Complications. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Length of Hospitalization Post-operation Primary · up to 12 months

days from operation date to discharge date

Group	Value	95% CI
Fast-track Surgery	8.92	± 2.029
Traditional Surgery	9.67	± 3.119

The Total Cost (RMB) Primary · 12 month

The total cost from hospitalization

Group	Value	95% CI
Fast-track Surgery	38882.44	± 8557.800
Traditional Surgery	42864.12	± 10166.535

CRP Secondary · up to 12 months

C-Reactive protein mg/L

Group	Value	95% CI
Fast-track Surgery	42.125	± 28.4284
Traditional Surgery	62.499	± 37.7870

Number of Participants With Complications Secondary · up to 12 months

Count of patients with complications in both groups are assessed during the first 21 days postoperatively. Including infection(wound infection, lung infection, intraperitoneal infection, operation space infection), postoperative nausea and vomiting (PONV) , ileus, postoperative hemorrhage, postoperative thrombosis.

Group	Value	95% CI
Fast-track Surgery	3
Traditional Surgery	13

Number of Participants With Infection, Secondary · up to 12 months

infection(wound infection, lung infection, intraperitoneal infection, operation space infection)

Group	Value	95% CI
Fast-track Surgery	2
Traditional Surgery	12

Number of Participants With Postoperative Nausea and Vomiting (PONV) Secondary · up to 12 months

it was recognized that nausea and vomiting are common side effects of surgical recovery

Group	Value	95% CI
Fast-track Surgery	0
Traditional Surgery	0

Number of Participants With Ileus Secondary · up to 12 months

is a disruption of the normal propulsive ability of the gastrointestinal tract

Group	Value	95% CI
Fast-track Surgery	1
Traditional Surgery	1

Number of Participants With Postoperative Haemorrhage Secondary · up to 12 months

Evidence of blood loss from drains or based on ultrasonography

Group	Value	95% CI
Fast-track Surgery	0
Traditional Surgery	0

Number of Participants With Postoperative Thrombosis Secondary · up to 12 months

Evidence of blood thrombosis of participants after surgery

Group	Value	95% CI
Fast-track Surgery	0
Traditional Surgery	0

PCT Calcitonin Postoperative Secondary · 12 month

value of calcitonin postoperative

Group	Value	95% CI
Fast-track Surgery	0.6275	± 0.90827
Traditional Surgery	0.7280	± 0.89083

Cost of Surgical Therapy Secondary · 12 month

Cost of surgical therapy (RMB)

Group	Value	95% CI
Fast-track Surgery	9703.22	± 1739.157
Traditional Surgery	9538.47	± 1548.385

Sponsor's own description

Fast-track surgery (FTS) pathway, also known as enhanced recovery after surgery (ERAS), FTS is a multidisciplinary approach aiming to accelerate recovery, reduce complications, minimize hospital stay without an increased readmission rate and reduce healthcare costs, all without compromising patient safety. It has been used successfully in non-malignant gynecological surgery, but it has been proven to be especially effective in elective colorectal surgery. However, no consensus guideline has been developed for gynecological oncology surgery although surgeons have attempted to introduce slightly modified FTS programmes for patients undergoing such surgery. NO randomised controlled trials for now.

The advantages of fast-track most likely extend to gynecology, although so far have scarcely been reported. There is a existing research showed FTS in gynecological oncology provide early hospital discharge after gynaecological surgery meanwhile with high levels of patient satisfaction.

The aim of this study is to identify patients following a FTS program who have been discharged earlier than anticipated after major gynaecological/gynaecological oncologic surgery and analyze the complication after surgery.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Perioperative enhanced recovery programmes for women with gynaecological cancers.
   Chau JPC, Liu X, Lo SHS, Chien WT, et al · · 2022 · cited 13× · PMID 35289396 · DOI 10.1002/14651858.cd008239.pub5
2. Fast-track surgery after gynaecological oncological surgery: study protocol for a prospective randomised controlled trial.
   Cui L, Shi Y, Zhang GN. · · 2016 · cited 2× · PMID 27978842 · DOI 10.1186/s13063-016-1688-3
3. Fast-track surgery applied in gynecological oncological surgical treatment: a prospective randomized trial.
   Shi X, Cui L, Shi Y, Zhang G, et al · · 2024 · PMID 40777928 · DOI 10.4314/ahs.v24i3.32
4. Fast-track surgery after gynaecological oncological surgery: A Prospective Randomized Trial
   Shi X, Cui L, Zhang G, Shi Y, et al · · 2020 · DOI 10.21203/rs.3.rs-22182/v1