Prognostic Factors Affecting Recurrence and Disease-Free Survival After Surgical Resection for Cancer Rectum

NCT ID: NCT06096493

Last Updated: 2023-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-01

Study Completion Date

2023-12-31

Brief Summary

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Tumor recurrence after curative surgical resection for rectal cancer is a serious complication that greatly affects the overall morbidity and the outcome. This study aims to identify the different prognostic factors affecting recurrence and disease-free survival after surgery.

Detailed Description

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A retrospective analysis of patients operated for cancer rectum with curative intent from.

Exclusion criteria will include patients with familial adenomatous polyposis, multiple synchronous or metachronous rectal cancers, and death within 3 months. Incomplete patients' files and patients that lost follow-up will be excluded.

Demographic, histopathological, follow up and outcome data will be collected from completed patients' files. Demographics include age, gender, family history, and chief complaint at the presentation. Histopathological data include tumor grade, vascular-perineural invasion, the total number of lymph nodes removed, and positive lymph nodes.

Lymph node ratio will be defined as the ratio of positive lymph nodes to the total number of retrieved lymph nodes in a histopathology specimen. Disease-free survival will be calculated for each patient based on the time of surgery to the time of recurrence detection.

Conditions

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Rectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with cancer rectum underwent curative surgery

Patients with cancer rectum underwent curative surgery

curative surgery for cancer rectum

Intervention Type PROCEDURE

Curative surgery for cancer rectum.

Interventions

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curative surgery for cancer rectum

Curative surgery for cancer rectum.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients who had curative surgery for cancer rectum.

Exclusion Criteria

* Patients with familial adenomatous polyposis (FAP), multiple synchronous or metachronous rectal cancers, and death within 3 months
* Patients that lost follow-up will be excluded.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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South Valley University

OTHER

Sponsor Role lead

Responsible Party

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Abdallah Mohamed Taha Aly

Assistant Professor of general Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Abdallah M Taha, MD

Role: PRINCIPAL_INVESTIGATOR

South Valley University, Egypt.

Locations

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Qena Faculty of Medicine, South Valley University Hospitals

Qina, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Abdallah M Taha, MD

Role: CONTACT

+201011716497

Facility Contacts

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Abdallah M Taha, MD

Role: primary

+201011617497

References

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He WZ, Xie QK, Hu WM, Kong PF, Yang L, Yang YZ, Jiang C, Yin CX, Qiu HJ, Zhang HZ, Zhang B, Xia LP. An increased number of negative lymph nodes is associated with a higher immune response and longer survival in colon cancer patients. Cancer Manag Res. 2018 Jun 18;10:1597-1604. doi: 10.2147/CMAR.S160100. eCollection 2018.

Reference Type BACKGROUND
PMID: 29950897 (View on PubMed)

Li Destri G, Di Carlo I, Scilletta R, Scilletta B, Puleo S. Colorectal cancer and lymph nodes: the obsession with the number 12. World J Gastroenterol. 2014 Feb 28;20(8):1951-60. doi: 10.3748/wjg.v20.i8.1951.

Reference Type BACKGROUND
PMID: 24587671 (View on PubMed)

Hashiguchi Y, Muro K, Saito Y, Ito Y, Ajioka Y, Hamaguchi T, Hasegawa K, Hotta K, Ishida H, Ishiguro M, Ishihara S, Kanemitsu Y, Kinugasa Y, Murofushi K, Nakajima TE, Oka S, Tanaka T, Taniguchi H, Tsuji A, Uehara K, Ueno H, Yamanaka T, Yamazaki K, Yoshida M, Yoshino T, Itabashi M, Sakamaki K, Sano K, Shimada Y, Tanaka S, Uetake H, Yamaguchi S, Yamaguchi N, Kobayashi H, Matsuda K, Kotake K, Sugihara K; Japanese Society for Cancer of the Colon and Rectum. Japanese Society for Cancer of the Colon and Rectum (JSCCR) guidelines 2019 for the treatment of colorectal cancer. Int J Clin Oncol. 2020 Jan;25(1):1-42. doi: 10.1007/s10147-019-01485-z. Epub 2019 Jun 15.

Reference Type BACKGROUND
PMID: 31203527 (View on PubMed)

Heald RJ, Husband EM, Ryall RD. The mesorectum in rectal cancer surgery--the clue to pelvic recurrence? Br J Surg. 1982 Oct;69(10):613-6. doi: 10.1002/bjs.1800691019.

Reference Type BACKGROUND
PMID: 6751457 (View on PubMed)

Tschmelitsch J, Kronberger P, Glaser K, Klingler A, Bodner E. Survival after surgical treatment of recurrent carcinoma of the rectum. J Am Coll Surg. 1994 Jul;179(1):54-8.

Reference Type BACKGROUND
PMID: 8019725 (View on PubMed)

Feeney G, Sehgal R, Sheehan M, Hogan A, Regan M, Joyce M, Kerin M. Neoadjuvant radiotherapy for rectal cancer management. World J Gastroenterol. 2019 Sep 7;25(33):4850-4869. doi: 10.3748/wjg.v25.i33.4850.

Reference Type BACKGROUND
PMID: 31543678 (View on PubMed)

Other Identifiers

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SVU-MED-SUR011-4-23-4-621

Identifier Type: -

Identifier Source: org_study_id

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