PRP Injection Into Anal Sphincters for Fecal Incontinence

The treatment of fecal incontinence after low anterior resection is problematic, and not always able to increase quality of life. Biofeedback and rehabilitation therapies are harmless and easy to use; thus, generally selected as the initial treatment modalities, however may be effective in a small portion of patients. More complex treatment techniques including sacral nerve stimulation decrease the severity of symptoms, however the implantation of the device is a costly, staged procedure. Little is known about the effectiveness of other techniques such as injectable substances on incontinence observed after low anterior resection. There is no study evaluating the safety and effectiveness of platelet rich plasma (PRP) injection for incontinent patients after low anterior resection.

Sex

All

Minimum age

18 Years

Maximum age

80 Years

Inclusion Criteria:

* incontinent patients after low anterior resection for rectal cancer

Exclusion Criteria:

* There are 2 types of exclusion criteria

A. Patients who will not be suitable for initial tests:

1. Patients younger than 18 or older than 80
2. Pregnant or lactating women
3. Patients received pelvic radiation after the initial cancer surgery
4. Patients with local recurrence
5. Patients with irresectable metastasis (patients with resectable liver and/or lung metastasis will be included after metastasectomy, but patients with peritoneal metastasis who will be candidate for peritonectomy will not be included)
6. Patients under chemotherapy
7. Patients confess incontinence prior to initial cancer surgery
8. Contraindication for PRP injection: active infection, thrombocytopenia, anemia (Hgb \<10 gr/dl), allergy for buffalo thrombin
9. If the interval after the final surgery less than 12 months
10. Patient refusal

B. Patients who will be excluded according to manometer and/or endoanal ultrasound findings. Only the patients with an acceptable volume of healthy anal sphincters, an adequate reservoir capacity of neorectum and decreased sphincter strength will be included to the study after ruling out a full-thickness external sphincter tear will be the subjects of the evaluation. These patients will be excluded prior to PRP injection:

1. If manometer reveals normal resting (59-74 mm) and squeeze (124-152 mm) pressure (No clue for decreased sphincter strength)
2. If manometer reveals higher than normal volume (17-23 cc) for the first sensation, since it shows reduction of rectal sensitivity
3. If manometer reveals lessened maximum tolerable volume (MTV), since the continence may be related to the reduced volume of neorectum (For healthy volunteers the normal level of MTV is between 216 cc and 266 cc. Although normal level for neorectum after low anterior resection is not known, in a study it is accepted to be more than 60 cc as the current study \[28\]).
4. No or minimal external sphincter volume during: for inclusion the length, wide and volume of the external sphincter should be at least 16.1 mm, 6.8 mm and 6.3 cc, respectively (for inclusion all 3 measures should fulfilled). Although the actual minimal volume of external sphincter preventing incontinence is not indicated, in this study the minimal volume in healthy volunteers has been accepted \[29,30\].
5. Endoanal ultrasound examination revealing full-thickness tear in external sphincter.

• BACKGROUNDZiv Y, Zbar A, Bar-Shavit Y, Igov I. Low anterior resection syndrome (LARS): cause and effect and reconstructive considerations. Tech Coloproctol. 2013 Apr;17(2):151-62. doi: 10.1007/s10151-012-0909-3. Epub 2012 Oct 18. PMID 23076289
• BACKGROUNDBryant CL, Lunniss PJ, Knowles CH, Thaha MA, Chan CL. Anterior resection syndrome. Lancet Oncol. 2012 Sep;13(9):e403-8. doi: 10.1016/S1470-2045(12)70236-X. PMID 22935240
• BACKGROUNDPeeters KC, van de Velde CJ, Leer JW, Martijn H, Junggeburt JM, Kranenbarg EK, Steup WH, Wiggers T, Rutten HJ, Marijnen CA. Late side effects of short-course preoperative radiotherapy combined with total mesorectal excision for rectal cancer: increased bowel dysfunction in irradiated patients--a Dutch colorectal cancer group study. J Clin Oncol. 2005 Sep 1;23(25):6199-206. doi: 10.1200/JCO.2005.14.779. PMID 16135487
• BACKGROUNDLundby L, Krogh K, Jensen VJ, Gandrup P, Qvist N, Overgaard J, Laurberg S. Long-term anorectal dysfunction after postoperative radiotherapy for rectal cancer. Dis Colon Rectum. 2005 Jul;48(7):1343-9; discussion 1349-52; author reply 1352. doi: 10.1007/s10350-005-0049-1. PMID 15933797
• BACKGROUNDRidolfi TJ, Berger N, Ludwig KA. Low Anterior Resection Syndrome: Current Management and Future Directions. Clin Colon Rectal Surg. 2016 Sep;29(3):239-45. doi: 10.1055/s-0036-1584500. PMID 27582649
• BACKGROUNDIshiyama G, Hinata N, Kinugasa Y, Murakami G, Fujimiya M. Nerves supplying the internal anal sphincter: an immunohistochemical study using donated elderly cadavers. Surg Radiol Anat. 2014 Dec;36(10):1033-42. doi: 10.1007/s00276-014-1289-3. Epub 2014 Apr 2. PMID 24691518
• BACKGROUNDKonanz J, Herrle F, Weiss C, Post S, Kienle P. Quality of life of patients after low anterior, intersphincteric, and abdominoperineal resection for rectal cancer--a matched-pair analysis. Int J Colorectal Dis. 2013 May;28(5):679-88. doi: 10.1007/s00384-013-1683-z. Epub 2013 Apr 10.