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A leak from a colorectal anastomosis is a post-operative complication surgeons fear the most, following colonic resection. Over the years, there have been multiple suggestions for intraoperative tests for the integrity of the colorectal anastomosis.
Two of the most common tests that are performed routinely are:
The aim of the study is to compare the two methods, and to assess if there is a superior method. A secondary aim is to establish standards to perform the test, mainly to assess the appropriate pressure to apply on the anastomosis.
In this prospective study patients scheduled to undergo colonic resection of their distal part of the colon/ rectum with colorectal anastomosis, will have both testing methods performed sequentially and will be followed post-operative to assess the yield and sensitivity of the testing methods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| colorectal resection and anastamosis | Other | Intraoperative testing of colorectal anastomoses
NB the above procedures are standard practice for assessing the quality of colorectal anastomoses during colorectal surgery. The purpose of the study is to compare these standard methods of evaluation to determinant which method is superior |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraoperative testing of colorectal anastomoses | Procedure |
NB the above procedures are standard practice for assessing the quality of colorectal anastomoses during colorectal surgery. The purpose of the study is to compare these standard methods of evaluation to determinant which method is superior |
| Measure | Description | Time Frame |
|---|---|---|
| the predictive value of intraoperative anastomosis testing on anastomotic leak. | The presence or absence of a post-operative clinical anastomotic leak | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| The sensitivity of the 2 methods of intraoperative anastomosis testing. | We will compare the occurence of air leak with the occurence of methylene blue leak in each patient | Both findings will be obvious (if present) immediately after the test is performed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yaron Rudnicki, MD | Contact | +972523263775 | yaron217@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Shmuel Avital, MD | Meir Medical Center, Israel | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33905010 | Derived | Rudnicki Y, White I, Tiomkin V, Lahav L, Raguan B, Avital S. Intraoperative evaluation of colorectal anastomotic integrity: a comparison of air leak and dye leak tests. Tech Coloproctol. 2021 Jul;25(7):841-847. doi: 10.1007/s10151-021-02453-4. Epub 2021 Apr 27. |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D004239 | Diverticulitis, Colonic |
| D057868 | Anastomotic Leak |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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|
| Stapled colorectal anastomoses | Procedure | After the resection we do the stapled colorectal anastomosis with a standard circular stapler as part of the regular procedure |
|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D004238 | Diverticulitis |
| D000076385 | Diverticular Diseases |
| D005759 | Gastroenteritis |
| D043963 | Diverticulosis, Colonic |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |