Clinical trial · Interventional
Near-Infrared Fluorescence Imaging With Indocyanine Green to Evaluate Bowel Anastomoses in Gynecologic Oncology Surgery
Evaluation of Bowel Anastomoses During Gynecologic Oncology Surgery Using Near-Infrared Fluorescence Imaging With Indocyanine Green
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this study is to evaluate if indocyanine green (ICG) fluorescence imaging helps reduce complications in bowel surgery performed during gynecologic cancer operations. The main question it aims to answer is: Does using ICG fluorescence imaging during bowel anastomosis reduce the rate of complications such as leaks, infections, and abscesses within 30 days after surgery? Participants are women aged 18 and older undergoing surgery for gynecologic cancers (such as ovarian, uterine, cervical, or vulvar cancer). During surgery, investigators will inject ICG intravenously, then use a special near-infrared camera to see how well blood flows at the anastomosis site. The investigators will then decide if the reconnection is good enough or needs adjustment. Researchers will record any complications within the first 30 days after surgery to understand if this imaging method helps reduce surgical risks.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anastomotic Leaks | — | UNRESOLVED | — |
| Cervical Cancers | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Endometrial Cancers | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Gynecologic Cancers | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Vulvar Cancer | Malignant Vulvar Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Indocyanine Green | Drug | — | UNRESOLVED |
| Near-Infrared Fluorescence Imaging System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ICG Fluorescence Imaging Group
- description
- Women undergoing gynecologic oncology surgery with bowel resection and anastomosis. Anastomotic perfusion will be evaluated intraoperatively using indocyanine green (ICG) enhanced near-infrared fluorescence imaging.
- interventionNames
- Drug: Indocyanine Green
- Device: Near-Infrared Fluorescence Imaging System
Primary outcomes (1)
- measure
- Rate of Anastomotic Complications within 30 Days After Surgery
- timeFrame
- 30 days after surgery
- description
- The primary outcome will be the incidence of anastomotic leaks, pelvic abscesses, and infections observed within 30 days following bowel anastomosis performed during gynecologic oncology surgery with indocyanine green-enhanced near-infrared fluorescence imaging.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients aged 18 years or older. * Diagnosis of gynecologic cancer (ovarian, endometrial, cervical, vulvar) requiring surgical treatment. * Planned bowel resection and anastomosis during gynecologic oncology surgery. * Ability and willingness to provide informed consent. Exclusion Criteria: * Known allergy or hypersensitivity to indocyanine green (ICG). * Pregnancy or breastfeeding at the time of surgery. * Severe liver or kidney dysfunction limiting the use of ICG.
References
Publications (7)
- BACKGROUNDEmile SH, Khan SM, Wexner SD. Impact of change in the surgical plan based on indocyanine green fluorescence angiography on the rates of colorectal anastomotic leak: a systematic review and meta-analysis. Surg Endosc. 2022 Apr;36(4):2245-2257. doi: 10.1007/s00464-021-08973-2. Epub 2022 Jan 13. PMID 35024926
- BACKGROUNDChan DKH, Lee SKF, Ang JJ. Indocyanine green fluorescence angiography decreases the risk of colorectal anastomotic leakage: Systematic review and meta-analysis. Surgery. 2020 Dec;168(6):1128-1137. doi: 10.1016/j.surg.2020.08.024. Epub 2020 Oct 1. PMID 33010938
- BACKGROUNDParthasarathy M, Greensmith M, Bowers D, Groot-Wassink T. Risk factors for anastomotic leakage after colorectal resection: a retrospective analysis of 17 518 patients. Colorectal Dis. 2017 Mar;19(3):288-298. doi: 10.1111/codi.13476. PMID 27474844
- BACKGROUNDBRUNSCHWIG A. Complete excision of pelvic viscera for advanced carcinoma; a one-stage abdominoperineal operation with end colostomy and bilateral ureteral implantation into the colon above the colostomy. Cancer. 1948 Jul;1(2):177-83. doi: 10.1002/1097-0142(194807)1:23.0.co;2-a. No abstract available. PMID 18875031
- BACKGROUNDGrimm C, Harter P, Alesina PF, Prader S, Schneider S, Ataseven B, Meier B, Brunkhorst V, Hinrichs J, Kurzeder C, Heitz F, Kahl A, Traut A, Groeben HT, Walz M, du Bois A. The impact of type and number of bowel resections on anastomotic leakage risk in advanced ovarian cancer surgery. Gynecol Oncol. 2017 Sep;146(3):498-503. doi: 10.1016/j.ygyno.2017.06.007. Epub 2017 Jun 10. PMID 28610745
- BACKGROUNDHarter P, Sehouli J, Lorusso D, Reuss A, Vergote I, Marth C, Kim JW, Raspagliesi F, Lampe B, Aletti G, Meier W, Cibula D, Mustea A, Mahner S, Runnebaum IB, Schmalfeldt B, Burges A, Kimmig R, Scambia G, Greggi S, Hilpert F, Hasenburg A, Hillemanns P, Giorda G, von Leffern I, Schade-Brittinger C, Wagner U, du Bois A. A Randomized Trial of Lymphadenectomy in Patients with Advanced Ovarian Neoplasms. N Engl J Med. 2019 Feb 28;380(9):822-832. doi: 10.1056/NEJMoa1808424.